A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis

September 1, 2021 updated by: FibroGen

A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There is a screening period of up to 6 weeks, a variable treatment period for individual participants. In order to complete the treatment period simultaneously for all study participants, the minimum treatment duration may be less than 52 weeks, with a maximum treatment duration of up to 3 years after the last participant is randomized, and a post-treatment follow-up period of 4 weeks. Participants who prematurely discontinued from treatment will be expected to complete the Early Termination (ET) and End of Study (EOS) visits. Such participants will be considered non-completers, but they will be expected to participate in long-term follow-up (LTFU) for cardiovascular events (CV) of interest, vital status, and hospitalizations until overall study closure unless the participant withdrew consent for this LTFU data collection. Participants were randomized in a 2:1 ratio to receive either roxadustat or placebo in a double-blind manner.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
922

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1852FZD
        • Investigational Site
      • Buenos Aires, Argentina, C1425BPJ
        • Investigational Site
      • Buenos Aires, Argentina, C1429BWN
        • Investigational Site
      • Cordoba, Argentina, 5000
        • Investigational Site
      • Cordoba, Argentina, X5002AOQ
        • Investigational Site
      • Cordoba, Argentina, X5016KET
        • Investigational Site
      • Corrientes, Argentina, 3400
        • Investigational Site
      • Mendoza, Argentina, 5500
        • Investigational Site
      • Salta, Argentina, A4402BGJ
        • Investigational Site
      • Santa Fe, Argentina, 3000
        • Investigational Site
    • Buenos Aires
      • Ciudad Evita, Buenos Aires, Argentina, B1178IFA
        • Investigational Site
      • Moron, Buenos Aires, Argentina, B1708DPN
        • Investigational Site
    • Provincia De Buenos Aires
      • González Catán, Provincia De Buenos Aires, Argentina, B1759LTF
        • Investigational Site
      • Junin, Provincia De Buenos Aires, Argentina, B6000GMA
        • Investigational Site
      • Pergamino, Provincia De Buenos Aires, Argentina, B2700CPM
        • Investigational Site
      • Villa Domínico, Provincia De Buenos Aires, Argentina, B1874GBA
        • Investigational Product
    • Provincia De Cordoba
      • Ciudad de Cordoba, Provincia De Cordoba, Argentina, X5002HWE
        • Investigational Site
  • Australia
      • Gosford, Australia, 2250
        • Investigational Site
      • Hobart, Australia, 7000
        • Investigational Site
      • Launceston, Australia, 7250
        • Investigational Site
      • Melbourne, Australia, 3004
        • Investigational Site
      • New Lambton Heights, Australia, 2305
        • Investigational Site
      • Randwick, Australia, 2031
        • Investigational Site
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Investigational Site
  • Chile
    • Region De La Araucania
      • Temuco, Region De La Araucania, Chile, 4781151
        • Investigational Site
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 8431657
        • Investigational Site
  • Colombia
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Investigational Site
  • Hong Kong
      • Chai Wan, Hong Kong
        • Investigational Site
      • Shatin, Hong Kong, 852
        • Investigational Site
      • Tai Po, Hong Kong
        • Investigational Site
    • Pokfulam
      • Hong Kong, Pokfulam, Hong Kong
        • Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 614-735
        • Investigational Site
      • Seoul, Korea, Republic of, 130-872
        • Investigational Site
      • Seoul, Korea, Republic of, 134-727
        • Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • Investigational Site
      • Seoul, Korea, Republic of, 133-791
        • Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • Investigational Site
      • Seoul, Korea, Republic of, 143-729
        • Investigational Site
      • Seoul, Korea, Republic of
        • Investigational Site
    • Gyeonggi-Do
      • Anyang-Si, Gyeonggi-Do, Korea, Republic of, 431-796
        • Investigational Site
      • Goyang-Si, Gyeonggi-Do, Korea, Republic of, 410-719
        • Investigational Site
      • Guri-Si, Gyeonggi-Do, Korea, Republic of, 471-701
        • Investigational Site
      • Seongnam-Si, Gyeonggi-Do, Korea, Republic of, 463-712
        • Investigational Site
  • Malaysia
      • Alor Setar, Malaysia, 05460
        • Investigational Site
      • Kajang, Malaysia, 43000
        • Investigational Site
      • Kuala Lumpur, Malaysia, 50586
        • Investigational Site
      • Kuala Lumpur, Malaysia, 59100
        • Investigational Site
      • Kuching, Malaysia, 93586
        • Investigational Site
      • Pulau Pinang, Malaysia, 10990
        • Investigational Site
      • Sungai Petani, Malaysia, 080000
        • Investigational Site
      • Taiping, Malaysia, 34000
        • Investigational Site
  • Mexico
      • Aguascalientes, Mexico, 20128
        • Investigational Site
      • San Luis Potosi, Mexico, 78240
        • Investigational Site
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 06100
        • Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Investigational Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64000
        • Investigational Site
    • Yucatan
      • Merida, Yucatan, Mexico, 97133
        • Investigational Site
  • New Zealand
      • Auckland, New Zealand
        • Investigational Site
      • Hamilton, New Zealand, 3240
        • Investigational Site
      • Tauranga, New Zealand, 3143
        • Investigational Site
  • Peru
      • Lima, Peru, Lima 13
        • Investigational Site
      • Lima, Peru, Lima 1
        • Investigational Site
    • Callao
      • Bellavista, Callao, Peru, Callao 2
        • Investigational Site
    • Lima
      • San Martin de Porres, Lima, Peru, Lima 31
        • Investigational Site
  • Philippines
      • Pasig, Philippines
        • Investigational Site
      • Quezon City, Philippines, 1100
        • Investigational Site
      • Quezon City, Philippines, 1102
        • Investigational Site
    • Cavite
      • Dasmarinas, Cavite, Philippines, 4114
        • Investigational Site
    • Davao
      • Davao City, Davao, Philippines, 8000
        • Investigational Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Investigational Site
      • San Juan, Puerto Rico, 00918
        • Investigational Site
  • Singapore
      • Singapore, Singapore, 119074
        • Investigational Site
      • Singapore, Singapore, 768828
        • Investigational Site
      • Singapore, Singapore
        • Investigational Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Investigational Site
      • Hualien City, Taiwan, 970
        • Investigational Site
      • Kaohsiung, Taiwan, 83301
        • Investigational Site
      • Kaohsiung, Taiwan, 40705
        • Investigational Site
      • Kaohsiung, Taiwan, 81362
        • Investigational Site
      • Taichung, Taiwan, 433
        • Investigational Site
      • Taichung, Taiwan, 40705
        • Investigational Site
      • Tainan, Taiwan, 704
        • Investigational Site
      • Tainan City, Taiwan, 433
        • Investigational Site
      • Taipei, Taiwan, 10002
        • Investigational Site
      • Taipei, Taiwan, 110
        • Investigational Site
      • Taipei, Taiwan, 11490
        • Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Investigational Site
      • Bangkok, Thailand, 10330
        • Investigational Site
      • Chiang Mai, Thailand, 50200
        • Investigational Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Investigational Site
    • Arizona
      • Tempe, Arizona, United States, 85284
        • Investigational Site
    • California
      • Alhambra, California, United States, 91801
        • Investigational Site
      • Chula Vista, California, United States, 91910
        • Investigational Site
      • Inglewood, California, United States, 90301
        • Investigational Site
      • La Mesa, California, United States, 91942
        • Investigational Site
      • La Palma, California, United States, 91324
        • Investigational Site
      • Lynwood, California, United States, 90262
        • Investigational Site
      • Northridge, California, United States, 91325
        • Investigational Site
      • Paramount, California, United States, 90723
        • Investigational Site
      • Riverside, California, United States, 92503
        • Investigational Site
      • Roseville, California, United States, 95661
        • Investigational Site
      • San Dimas, California, United States, 91773
        • Investigational Site
      • Whittier, California, United States, 90603
        • Investigational Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Investigational Site
      • Cutler Bay, Florida, United States, 33157
        • Investigational Site
      • Hialeah, Florida, United States, 33016
        • Investigational Site
      • Miami, Florida, United States, 33135
        • Investigational Site
      • Miami, Florida, United States, 33015
        • Investigational Site
      • Miami, Florida, United States, 33122
        • Investigational Site
      • Miami, Florida, United States, 33150
        • Investigational Site
      • Ocala, Florida, United States, 34471
        • Investigational Site
      • Pembroke Pines, Florida, United States, 33028
        • Investigational Site
      • South Miami, Florida, United States, 33143
        • Investigational Site
      • Winter Park, Florida, United States, 32789
        • Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Investigational Site
    • Idaho
      • Caldwell, Idaho, United States, 83605
        • Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Investigational Site
      • Flint, Michigan, United States, 48503
        • Investigational Site
      • Flint, Michigan, United States, 48532
        • Investigational Site
      • Pontiac, Michigan, United States, 48341
        • Investigational Site
      • Roseville, Michigan, United States, 48066
        • Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Investigational Site
    • New York
      • Bronx, New York, United States, 10461
        • Investigational Site
      • Mineola, New York, United States, 11501
        • Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Investigational Site
      • Rocky Mount, North Carolina, United States, 27804
        • Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Investigational Site
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Investigational Site
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Investigational Site
      • Sumter, South Carolina, United States, 29150
        • Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Investigational Site
    • Texas
      • Arlington, Texas, United States, 76015
        • Investigational Site
      • Corsicana, Texas, United States, 75110
        • Investigational Site
      • Dallas, Texas, United States, 75246
        • Investigational Site
      • Houston, Texas, United States, 77030
        • Investigational Site
      • San Antonio, Texas, United States, 78229
        • Investigational Site
    • Virginia
      • Fairfax, Virginia, United States, 22033
        • Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic kidney disease Stages 3, 4, or 5 and not receiving dialysis
  • Anemia qualified by measurements of hemoglobin values during screening
  • Additional blood work must be in a safe range for study entry
  • Body weight 45 to 160 kilograms (kg)
  • Willingness to use contraception if of child-bearing potential

Exclusion Criteria:

  • Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to study participation
  • More than 1 dose of intravenous iron within 12 weeks prior to study participation
  • Blood transfusion within 8 weeks prior to study participation
  • Active infection
  • Chronic liver disease
  • Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot
  • Uncontrolled blood pressure within 2 weeks prior to study participation
  • Renal cell carcinoma
  • History of malignancy, including multiple myeloma or other myelodysplastic syndrome
  • Chronic inflammatory disease that could impact red blood cell production
  • Any prior organ transplant or a scheduled organ transplantation
  • Anticipated elective surgery that is expected to lead to significant blood loss or anticipated elective heart procedure
  • Gastrointestinal bleeding
  • Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
  • Recent use of an investigational drug or treatment, or participation in an investigational study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Roxadustat
Participants will receive roxadustat tablets orally 3 times a week (TIW). The initial dose will be according to the tiered weight-based approach, with starting roxadustat doses of 70 milligrams (mg) TIW to participants weighing <70 kilograms (kg) and roxadustat doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) will be performed based upon regular measurement of Hb levels until the participant achieves central Hb value of ≥11.0 grams/deciliter (g/dL) and Hb increase from baseline (BL) of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level is reached, the participant will enter the maintenance period during which roxadustat dosage will be adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration will be up to 234.9 weeks.
Drug: Roxadustat
Oral tablets
Other Names:
  • FG-4592
  • ASP1517
  • AZD9941
Placebo Comparator: Placebo
Participants will receive roxadustat-matching placebo tablets orally TIW. The initial dose will be according to the tiered weight-based approach, with starting roxadustat-matching placebo doses of 70 mg TIW to participants weighing <70 kg and roxadustat-matching placebo doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) will be performed based upon regular measurement of Hb levels until the participant achieves central Hb value of ≥11.0 g/dL and Hb increase from BL of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level is reached, the participant will enter the maintenance period during which roxadustat dosage will be adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration will be up to 208.1 weeks.
Drug: Placebo
Oral tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy
Time Frame: Baseline (Day 1, Week 0), Weeks 28 to 52
The change in Hb from baseline to the average level during the evaluation period (defined as Week 28 until Week 52) is reported. Hb values under the influence of a rescue therapy were not censored. The intermittent missing hemoglobin data were imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model, Monotone missing data were imputed by regression from its own treatment group. Baseline Hb was defined as the mean of up to 4 last central laboratory values prior to the first dose of study drug.
Baseline (Day 1, Week 0), Weeks 28 to 52
Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy
Time Frame: Baseline up to Week 24

The number of participants who achieved a Hb response at 2 consecutive visits at least 5 days apart during the first 24 weeks of treatment, without rescue therapy (that is, red blood cell [RBC] transfusion, erythropoiesis-stimulating agent [ESA], or intravenous [IV] iron) are reported. A Hb response is defined, using central laboratory values, as the following:

  • Hb ≥11 g/dL and Hb increase from baseline by ≥1 g/dL in participants with baseline Hb >8 g/dL, or
  • An increase in Hb by ≥2 g/dL in participants with baseline Hb ≤8.0 g/dL
Baseline up to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Hb Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy
Time Frame: Baseline (Day 1, Week 0), Weeks 28 to 36
For Ex-US submission only: Hb values under the influence of a rescue therapy were censored by mixed effect model of repeated measures (MMRM) for up to 6 weeks. Baseline Hb was defined as the mean of up to 4 last central laboratory values prior to the first dose of study drug.
Baseline (Day 1, Week 0), Weeks 28 to 36
Mean Change From Baseline in Hb Averaged Over Weeks 28 to 52 Regardless of Rescue Therapy in Participants With Baseline C-Reactive Protein (CRP) >Upper Limit of Normal (ULN)
Time Frame: Baseline (Day 1, Week 0), Weeks 28 to 52
Hb values under the influence of a rescue therapy were not censored in the analysis. The intermittent missing hemoglobin data were imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model, Monotone missing data were imputed by regression from its own treatment group. Baseline Hb was defined as the mean of up to 4 last central laboratory values prior to the first dose of study treatment.
Baseline (Day 1, Week 0), Weeks 28 to 52
Number (%) of Participants With Hb ≥10 g/dL Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy
Time Frame: Weeks 28 to 36
Hb values under the influence of a rescue therapy were censored by Cochran-Mantel-Haenszel Test for up to 6 weeks. Responder was defined as: Hb ≥10.0 g/dL, which was based on central laboratory values.
Weeks 28 to 36
Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 28
Time Frame: Baseline (Day 1, Week 0), Weeks 12 to 28
Baseline LDL cholesterol was defined as the last LDL cholesterol value prior to the first dose of study drug.
Baseline (Day 1, Week 0), Weeks 12 to 28
Rate of Change in eGFR From Baseline up to 12 Months (Linear Random Coefficient Model With Observed Data)
Time Frame: Baseline, Month 12
Progression of chronic kidney disease was measured by rate of change in eGFR over time adjusted by baseline eGFR, with censoring for chronic dialysis or kidney transplant, using random slope and intercept model. Least Square Mean of change from baseline at 1 year was derived based on a random slopes and intercepts model using all available eGFR values (1 baseline and all post-treatment values up to end of treatment period + 7 days or start of dialysis) adjusted on treatment, baseline Hb, baseline eGFR, geographical region, cardiovascular events history at Baseline (yes vs. no), time (continuous value), the interaction terms of baseline eGFR by time, baseline Hb by time, and treatment by time as fixed effects, with random effects of intercept and linear slope of time. All assessments collected after the start of stable dialysis or kidney transplant were excluded from the analysis.
Baseline, Month 12
Number of Participants Who Received Blood/RBC Transfusion in the First 52 Weeks of Treatment
Time Frame: Baseline up to Week 52
Participants with any use of blood/RBC transfusion were reported.
Baseline up to Week 52
Number (%) of Participants Who Received Rescue Therapy in the First 24 Weeks and in the First 52 Weeks of Treatment
Time Frame: Baseline (Day 1, Week 0) up to Week 24 and up to Week 52
Rescue therapy included any use of RBC transfusion, ESA, or IV iron.
Baseline (Day 1, Week 0) up to Week 24 and up to Week 52
Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 12 to 28
Time Frame: Baseline (Day 1, Week 0), Weeks 12 to 28
The SF-36 V2 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The physical functioning subscore and vitality subscore are reported. The scores ranged from 0 (worst) to 100 (Best). A higher score indicates a general improvement of life quality or well-being. Baseline score was defined as the last physical functioning value or vitality value, as applicable, prior to the first dose of study drug.
Baseline (Day 1, Week 0), Weeks 12 to 28
Number (%) of Participants Who Experienced Exacerbation of Hypertension
Time Frame: Baseline up to Week 52
Exacerbation of hypertension was defined as an increase from baseline of ≥20 millimeter of mercury (mmHg) in systolic blood pressure (sBP) and sBP ≥170 mmHg or an increase from baseline of ≥15 mmHg in diastolic blood pressure (dBP) and dBP ≥110 mmHg.
Baseline up to Week 52
Mean Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 20 to 28
Time Frame: Baseline, Weeks 20 to 28
Baseline MAP was defined as the last MAP value prior to the first dose of study drug.
Baseline, Weeks 20 to 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
FibroGen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AstraZeneca
Astellas Pharma Europe B.V.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mark Eisner, MD, MPH, FibroGen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 24, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FGCL-4592-060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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