A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) (PODO)

April 16, 2024 updated by: Pfizer

A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)

The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusions in adult subjects with FSGS.

Study Overview

Status

Status

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

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.

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.
47

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 2

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

  • Canada
      • Quebec, Canada, G1R 2J6
        • CHU de Quebec-Universite Laval
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
      • Edmonton, Alberta, Canada, T6G 1Z1
        • University of Alberta - Pharmacy Research Office
      • Edmonton, Alberta, Canada, T6G 287
        • University of Alberta - Clinical Investigation Unit
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Pacific Nephrology Group
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital/Vancouver Coastal Health
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital/Providence Health Care
      • Vancouver, British Columbia, Canada, V6Z 2K8
        • St. Paul's Hospital/Providence Health Care
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network
      • Toronto, Ontario, Canada, M4G 3E8
        • Sunnybrook Health Sciences Centre - Kidney Care Centre at the CNIB
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l'Est-de-l'Ile-de-Montreal - installation Hopital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada, H4A 3J1
        • Centre for Innovative Medicine, Research Institute of the McGill University Health Centre
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Praha 2, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze
  • France
      • Creteil, France, 94010
        • Hopital Henri Mondor
      • Nice Cedex 1, France, 06001
        • CHU de Nice - Hopital Pasteur
      • Paris, France, 75015
        • Hôpital Necker - Enfants Malades
  • Germany
      • Aachen, Germany, 52074
        • Universitaetsklinikum Aachen
      • Berlin, Germany, 10117
        • Charite - Universitaetsmedizin Berlin
      • Erlangen, Germany, 91054
        • Universitaetsklinikum Erlangen
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Koeln, Germany, 50937
        • Uniklinik Koeln
      • Mannheim, Germany, 68167
        • Universitaetsklinikum Mannheim
      • Villingen-Schwenningen, Germany, 78052
        • Nephrologisches Zentrum Villingen-Schwenningen
      • Villingen-Schwenningen, Germany, 78052
        • Sidonia Apotheke
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Universitätsklinikum Dresden, Medizinische Klinik III, Nephrologie
  • Italy
      • Bergamo, Italy, 24127
        • ASST Papa Giovanni XXIII
    • Pavia
      • Pavia PV, Pavia, Italy, 27100
        • Ics Maugeri Spa-Sb Irccs
  • Japan
      • Chiba, Japan, 260-8712
        • National Hospital Organization Chiba-East Hospital
      • Niigata, Japan, 951-8510
        • Niigata University Medical & Dental Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
        • Nagoya University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Osaka University Hospital
  • Mexico
      • Mexico City, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
      • Queretaro, Mexico, 76070
        • SMIQ S de RL de CV
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64460
        • Hospital Universitario "Dr Jose Eleuterio Gonzalez"
  • Poland
      • Lodz, Poland, 92-213
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej
      • Lodz, Poland, 92-216
        • Apteka Szpitalna SPZOZ
      • Warszawa, Poland, 04-749
        • Międzyleski Szpital Specjalistyczny w Warszawie
      • Warszawa, Poland, 00-631
        • Centrum Zdrowia MDM
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
      • Banska Bystrica, Slovakia, 975 01
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
      • Bratislava, Slovakia, 831 01
        • Univerzitna nemocnica Bratislava
      • Bratislava, Slovakia, 833 40
        • Narodny ustav detskych chorob
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
    • Lugo
      • Burela, Lugo, Spain, 27880
        • Hospital Público da Mariña
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
      • Coventry, United Kingdom, CV2 2DX
        • University Hospitals Coventry & Warwickshire NHS Trust
      • London, United Kingdom, W12 0HS
        • Hammersmith Hospital
      • London, United Kingdom, SW17 0QT
        • St. George's University Hospitals NHS Foundation Trust
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust
    • Oxford
      • Headington, Oxford, United Kingdom, OX3 7LE
        • Oxford University Hospitals NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • The Kirklin Clinic of University Alabama Birmingham Hospital
      • Birmingham, Alabama, United States, 35249
        • Investigational Drug Service Pharmacy UAB Hosptial
      • Birmingham, Alabama, United States, 35294
        • Clinical Research Unit at UAB Hospital
      • Birmingham, Alabama, United States, 35294
        • UAB Nephrology Research Clinic at Paula Building
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA Department of Medicine
      • Los Angeles, California, United States, 90022
        • Academic Medical Research Institute
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Comprehensive Transplant Center
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Ambulatory Infusion Center
      • Los Angeles, California, United States, 90095
        • UCLA Clinical and Translational Research Center
      • Palo Alto, California, United States, 94304
        • Clinical and Translation Research Unit
      • Palo Alto, California, United States, 94304
        • Stanford University-Nephrology Division
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • Stanford, California, United States, 94305
        • Stanford University
      • Stanford, California, United States, 94305
        • Stanford Health Care Investigational Pharmacy
      • Stanford, California, United States, 94305
        • Stanford University-Nephrology Division
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University
      • New Haven, Connecticut, United States, 06510
        • Yale Nephrology Clinical Research Clinic
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine - Yale-New Haven Hospital
      • New Haven, Connecticut, United States, 06519
        • Yale Center for Clinical Investigation - Church Street Research Unit
      • New Haven, Connecticut, United States, 06511
        • Yale New Haven Hospital
      • New Haven, Connecticut, United States, 06510
        • Yale Center for Clinical Investigation Hospital Research Unit
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States, 33136
        • University of Miami Hospital and Clinics
      • Miami, Florida, United States, 33136
        • University of Miami Katz Family Division of Nephrology
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Georgia Nephrology Research Institute
      • Lawrenceville, Georgia, United States, 30046
        • Georgia Nephrology
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Johnson County Clin Trials
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center - Interventional Radiology
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center - Nephrology
      • Boston, Massachusetts, United States, 02118
        • Boston University - GCRU
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital
      • Kansas City, Missouri, United States, 64111
        • Clinical Research Consultants, LLC
    • New York
      • New York, New York, United States, 10016
        • New York University Grossman School of Medicine - CTSI
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Eastowne
      • Chapel Hill, North Carolina, United States, 27599-7064
        • UNC Clinical and Translational Research Center
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • University of Cincinnati at DCI McMillan Research Unit
      • Cincinnati, Ohio, United States, 45219
        • Hoxworth Center Subspecialties Clinic
      • Cincinnati, Ohio, United States, 45219
        • UC Health Barrett Center
      • Cincinnati, Ohio, United States, 45219
        • UC Health Medical Arts Building
      • Cincinnati, Ohio, United States, 45229
        • University of Cincinnati Gardner Neuroscience Institute
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic - Investigational Drug Pharmacy
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Investigational Drug Services
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
      • Columbus, Ohio, United States, 43203
        • CarePoint East at The Ohio State University
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Clinical Research Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center- Nephrology Clinical Trials Unit
    • Texas
      • Houston, Texas, United States, 77004
        • Kidney and Hypertension Care Center, PA
      • Houston, Texas, United States, 77030
        • Southside Pharmacy
      • Houston, Texas, United States, 77054
        • Prolato Clinical Research Center (PCRC)
      • Temple, Texas, United States, 76502
        • Baylor Scott & White Clinic - Temple South Loop

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

Description

Inclusion Criteria:

  1. Adults age 18 years and older who have a confirmed biopsy diagnosis of FSGS.
  2. Estimated glomerular filtration rate (eGFR) greater than or equal to 45 ml/min/1.73 m2. If eGFR is 30 - 45 ml/min/1.73 m2, a recent biopsy (within 12 months prior to Screening) must demonstrate < 50% tubulointerstitial fibrosis.
  3. Urine protein:creatinine ratio (UPCR) greater than 1.5 g/g at screening.
  4. Treated with at least one but not more than 3 classes of immunosuppressants either alone or in combination, or has a contraindication to use of an immunosuppressant or is intolerant to an immunosuppressant per investigator judgment.

Exclusion Criteria:

  1. Diagnosis of collapsing FSGS.
  2. Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis.
  3. Organ transplant.
  4. History of malignancy, with the exception of basal or squamous cell carcinoma that has been treated and fully resolved for a minimum of 5 years.
  5. Body mass index (BMI) greater than 45 kg/m2.
  6. Subjects with a history of prior treatment with or use of interferon, lithium, pamidronate, mTOR inhibitors (eg, sirolimus), testosterone/anabolic steroids, anthracycline (eg, doxorubicin), heroin.

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

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: PF-06730512 Cohort 1
Subjects in cohort 1 will receive dose 1 Intravenous (IV) infusion.
Drug: PF-06730512
Subjects in cohort 1 will receive Dose 1 Intravenous infusion (IV). Subjects in cohort 2 will receive Dose 2 IV. Subjects in cohort 3 will receive Dose 3 IV infusion.
Experimental: PF-06730512 Cohort 2
Subjects in cohort 2 will receive dose 2 IV infusion.
Drug: PF-06730512
Subjects in cohort 1 will receive Dose 1 Intravenous infusion (IV). Subjects in cohort 2 will receive Dose 2 IV. Subjects in cohort 3 will receive Dose 3 IV infusion.
Experimental: PF-06730512 Cohort 3 (optional)
Subjects in cohort 3 will receive dose 3 IV infusion.
Drug: PF-06730512
Subjects in cohort 1 will receive Dose 1 Intravenous infusion (IV). Subjects in cohort 2 will receive Dose 2 IV. Subjects in cohort 3 will receive Dose 3 IV infusion.

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
Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13
Time Frame: Baseline, Week 13
UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function.
Baseline, Week 13

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
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: From Day 1 of treatment up to 9 weeks after last dose of study treatment (up to Week 33)
An adverse event was considered treatment emergent relative to a given treatment if the event occurred for the first time during the investigational treatment period and was not seen prior to the start of treatment (during the lead-in period), or the event was seen prior to the start of treatment but increased in severity during treatment. Adverse events occurring during the lead-in period were considered non-treatment emergent. Events that occurred during the follow-Up period were counted as treatment emergent and attributed to the previous treatment taken.
From Day 1 of treatment up to 9 weeks after last dose of study treatment (up to Week 33)
Number of Participants With Abnormalities in Laboratory Test Parameters
Time Frame: From Day 1 of treatment up to Week 33
Hemoglobin (Hg), hematocrit, erythrocytes: <0.8*lower limits of normal (LLN); platelets: <0.5*LLN>1.75*upper limits of normal(ULN); leukocytes (leu), glucose-fasting:<0.6*LLN>1.5*ULN; lymphocytes (lym), lym/leu, neutrophils(neu),neu/leu, protein, albumin, phosphate, free thyroxine, thyroid stimulating hormone: <0.8*LLN>1.2*ULN; basophils (bas), bas/leu, eosinophils (eos), eos/leu, monocytes(mon), mon/leu: >1.2*ULN; bilirubin (total, direct, indirect):>1.5*ULN; aspartate aminotransferase(AT), alanine AT, lactate dehydrogenase, alkaline phosphatase:>3.0*ULN; blood urea nitrogen, creatinine, cholesterol (total,LDL,HDL),triglycerides, Hg A1C: >1.3*ULN; sodium: <0.95*LLN>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate: <0.9*LLLN>1.1*ULN; prolactin: >1.1*ULN; creatine kinase: >2.0*ULN; urobilinogen: >=1; Urine-specific gravity: <1.003>1.030, pH: <4.5 >8, glucose,protein,bilirubin,nitrite,leukocyte esterase, ketones: >=1.Categories with at-least 1 non-zero values are reported.
From Day 1 of treatment up to Week 33
Change From Baseline in Body Weight
Time Frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33
Change from baseline in body weight and at baseline values were reported for this outcome measure.
Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33
Change From Baseline in Blood Pressure
Time Frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33
Change from baseline in blood pressure and at baseline values were reported for this outcome measure.
Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33
Change From Baseline in Pulse Rate
Time Frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33
Change from baseline in pulse rate and at baseline values were reported for this outcome measure.
Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33
Change From Baseline in Body Temperature
Time Frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33
Change from baseline in body temperature and at baseline values were reported for this outcome measure.
Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Time Frame: Weeks 3, 7, 11, 13, 17, 21, 25, 33
ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcB) in millisecond (msec): greater than (>) 450, >480, >500, increase from baseline >30, increase from baseline >60; 2) QTc interval adjusted according to Fridericia formula (QTcF) (msec): >450, >480, >500, increase from baseline >30, increase from baseline >60; 3) Heart rate (bpm): RR decrease >25% and to a VR (interval between QRS wave and T wave on ECG) >100; RR (interval between 2 successive R waves on ECG) increase >25% and to a VR <50; 4) Pulse rate (msec): increase >25% and to a value >200; 5) QT (msec): >450, >480, >500, increase from baseline >30, increase from baseline >60; 6) QRS (msec): increase >25% and to a value >110. Categories (timepoints) with at least 1 participant having ECG abnormality in any of the reporting arms, were reported for this outcome measure.
Weeks 3, 7, 11, 13, 17, 21, 25, 33
Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13
Time Frame: Baseline, Weeks 2, 5, 9 and 13
UPCR is a ratio between two measured substances in urine: mmol of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function.
Baseline, Weeks 2, 5, 9 and 13
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13
Time Frame: Baseline, Weeks 3, 5, 9 and 13
The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration, age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) = 175*(sCr/88.4)^-1.154*(Age)^-0.203*(0.742 if female)*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1). For Baseline eGFR, the "Low eGFR" group was defined as baseline eGFR < 45 mL/min/1.73m2, and the "High eGFR" group was defined as baseline eGFR > 45 mL/min/1.73 m2.
Baseline, Weeks 3, 5, 9 and 13
Serum PF-06730512 Concentration Versus Time Summary
Time Frame: For 12-Week treatment(WT):pre-dose on Day1,8,15,29,43,57,71,follow-up(Fup)visit on Day85,99,113,141,For 24-WT:pre-dose on Day1,8,15,29,43,57,71,85,99,113,127,141,155,Fup visit on Day169,183,197,225;1hour post-dose on Day1,71,155(only applicable for 24-WT)
For 12-Week treatment(WT):pre-dose on Day1,8,15,29,43,57,71,follow-up(Fup)visit on Day85,99,113,141,For 24-WT:pre-dose on Day1,8,15,29,43,57,71,85,99,113,127,141,155,Fup visit on Day169,183,197,225;1hour post-dose on Day1,71,155(only applicable for 24-WT)
Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb)
Time Frame: From Day 1 of treatment up to Week 33
Number of participants with positive ADA and/or NAb were reported for this outcome measure.
From Day 1 of treatment up to Week 33

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.
Pfizer

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 Director: Pfizer CT.gov Call Center, Pfizer

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

Helpful Links

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.
October 15, 2018

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.
February 14, 2023

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.
February 14, 2023

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).
February 22, 2018

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.
February 22, 2018

First Posted (Actual)

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.
February 28, 2018

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.
April 18, 2024

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.
April 16, 2024

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.
April 1, 2024

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.
  • C0221002
  • 2019-003607-35 (EudraCT Number)
  • ROBO2 (Other Identifier: Alias Study Number)
  • PODO (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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