Study of Phosphate Levels in Patients With Chronic Kidney Disease (PA21)

March 3, 2014 updated by: Vifor Pharma

An Open-label, Randomised, Active Controlled Multi-center Phase II Dose Finding Study to Evaluate the Ability of PA21 to Lower Serum Phosphate Levels and the Tolerability in Patients With Chronic Kidney Disease on Maintenance Hemodialysis

The purpose of this study is to investigate the ability of different doses of PA21 to lower serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.

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.

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.
154

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

  • Bulgaria
      • Gabrovo, Bulgaria, 5300
        • MHAT
      • Plovdiv, Bulgaria, 4003
        • MHAT Plovdiv
      • Ruse, Bulgaria, 7002
        • Department of Haemodialysis at MHAT
      • Sofia, Bulgaria, 1233
        • 5th MHAT Sofia
      • Sofia, Bulgaria, 1309
        • SHATCVD - National Cardiology Hospital
      • Sofia, Bulgaria, 1407
        • MHAT "Tokuda Hospital Sofia"
      • Sofia, Bulgaria, 1431
        • UMHAT "Alexandrovska" Dialysis Clinic
      • Sofia, Bulgaria, 1431
        • UMHAT "Sveti Ivan Rilski"
      • Sofia, Bulgaria, 1784
        • UMHAT "Sveta Anna"
      • Veliko Tarnovo, Bulgaria, 5000
        • MDHAT Department of Haemodialysis and Nephrology
  • Croatia
      • Bjelovar, Croatia, 43000
        • Opca bonica Bjelovar
      • Karlovac, Croatia, 47000
        • Opca bolnica Karlovac
      • Koprivnica, Croatia, 48000
        • Opca bolnica
      • Osijek, Croatia, 31000
        • Klinicka bolnica Osijek
      • Rijeka, Croatia, 51000
        • Klinicki Bolnicki Centar Rijeka
      • Split, Croatia, 21000
        • Klinički Bolnički Centar Split
      • Zadar, Croatia, 23000
        • Opca bolnica Zadar
      • Zagreb, Croatia, 10000
        • Klinicka bolnica
      • Zagreb, Croatia, 10000
        • Poliklinika Sveti Duh II
      • Zagreb, Croatia, 10040
        • Klinicka bolnica Dubrava
  • Czech Republic
      • Brno, Czech Republic, 60200
        • Innef a.s. Hemodialyzancni stredisko
      • Nove Město na Morave, Czech Republic, 59231
        • Nemocnice Nove Mesto na Morave
      • Novy Jicin, Czech Republic, 74101
        • Nemocnice s poliklinikou v Novem Jicine
      • Prague, Czech Republic, 2
        • Klinika nefrologie VFN
  • Germany
      • Dortmund, Germany, 44263
        • Nephrologische Gemeinschaftspraxis und Dialysezentrum
      • Herne, Germany, 44625
        • Marienhospital
  • Poland
      • Golub-Dobrzyń, Poland, 87-400
        • Niepubliczny Zaklad Opieki Zdrowotnej
      • Katowice, Poland, 40-027
        • Katedra i Klinika Nefrologii
      • Olkusz, Poland, 32-300
        • NZOZ Dializa
      • Poznań, Poland, 60-355
        • Katedra i Klinika Nefrologii
      • Siedlce, Poland, 26
        • Samodzielny Specjalistyczny
      • Sieradz, Poland, 98-200
        • Niepubliczny Zaklad Opieki Zdrowotnej
      • Warszawa, Poland, 01-809
        • Centrum Dializy i Diagnostyki
  • Romania
      • Bucuresti, Romania, 050098
        • Spitalul Universitar de Urgenta Bucuresti
      • Bucuresti, Romania, 022328
        • Institutul Clinic Fundeni
      • Lasi, Romania, 700503
        • Spitalul Clinic
      • Oradea, Romania, 410562
        • SC Renamed Nefrodial SRL
      • Targu Mures, Romania, 540136
        • S.C. Avitum S.R.L
  • Russian Federation
      • Kazan, Russian Federation, 420064
        • GOU VPO Kazan
      • Moscow, Russian Federation, 125284
        • GUZ City Clinical Hospital
      • Novosibirsk, Russian Federation, 630120
        • MUZ City Clinical Hospital
      • Smolensk, Russian Federation, 214001
        • MLPU Clinical City Hospital
      • St. Petersburg, Russian Federation, 191104
        • Saint-Petersburg CUS City Mariinskaya Hospital
      • St. Petersburg, Russian Federation, 195257
        • Saint-Petersburg GUZ City Clinical Hospital
      • St. Petersburg, Russian Federation, 195607
        • GOU VPO
      • St. Petersburg, Russian Federation, 196247
        • Saint-Petersburg GUZ City Hospital
      • St. Petersburg, Russian Federation, 197089
        • GOU VPO
      • St.Petersburg, Russian Federation, 198205
        • CUS City Hospital
  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonspital Aarau
      • Lausanne, Switzerland, 1011
        • CHUV Lausanne
      • Zürich, Switzerland, 8091
        • Universitatsspital Zurich
  • United States
    • Colorado
      • Arvada, Colorado, United States, 80002
        • Western Nephrology & Metabolic Disease
      • Denver, Colorado, United States, 80220
        • Complete Renal Care
    • Florida
      • Pembroke Pines, Florida, United States, 33028
        • Pines Clinical Research
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • New York
      • Fresh Meadows, New York, United States, 11365
        • Nephrology Associates
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals / Case Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Southeast Renal Research Institute
      • Nashville, Tennessee, United States, 37205
        • Nephrology Associates
    • Texas
      • Houston, Texas, United States, 77099
        • Southwest Houston Research

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

Main Inclusion Criteria:

  • ≥ 18 years of age,
  • Receiving stable maintenance hemodialysis 3 times a week
  • On restricted phosphate diet at screening and throughout study
  • Receiving stable dose of phosphate binder for at least 1 month
  • Serum phosphate levels >1.78 mmol/L

Main Exclusion Criteria:

  • Uncontrolled hyperphosphatemia
  • Hypercalcemia at screening or during washout
  • Serum calcium < 1.9 mmol/L (<7.6 mg/dL)
  • Severe hyperparathyroidism (iPTH levels >600 ng/L)
  • Pregnancy or lactation
  • Iron deficiency anemia
  • History of hemochromatosis or ferritin >800 mg/L,
  • Hepatitis B, hepatitis C or other significant concurrent liver disorders
  • Known positivity to HIV
  • Use of oral iron preparations 1 month before screening,
  • Serious medical condition or uncontrolled systemic disease

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: None (Open Label)

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: 1.25 g PA21
Drug: 1.25 g PA21 (250 mg iron)
Daily dose of 1.25 g PA21 (1 tablet/day) for 6 weeks. One PA21 tablet will be taken orally with the largest meal of the day.
Experimental: 5.0 g PA21
Drug: 5.0 g PA21 (1,000 mg iron)
Daily dose of 5.0 g PA21 (4 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with the largest meal of the day, and one PA21 tablet will be taken orally with each of the two smaller main meals of the day (3 meals per day).
Experimental: 7.5 g PA21
Drug: 7.5 g PA21 (1,500 mg iron)
Daily dose of 7.5 g PA21 (6 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with each of the three main meals of the day (3 meals per day).
Experimental: 10.0 g PA21
Drug: 10.0 g PA21 (2,000 mg iron)
Daily dose of 10.0 g PA21 (8 tablets/day) for 6 weeks. Four PA21 tablets will be taken orally with the largest meal of the day, and two PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
Experimental: 12.5 g PA21
Drug: 12.5 g PA21 (2,500 mg iron)
Daily dose of 12.5 g PA21 (10 tablets/day) for 6 weeks. Four tablets will be taken orally with the largest meal of the day, and three PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
Experimental: Sevelamer hydrochloride - active control
Drug: Sevelamer hydrochloride
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets/day) for 6 weeks. Two Sevelamer tablets will be taken orally with each of the three main meals of the day (3 meals per day).

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
Time Frame
Change From Baseline in Serum-phosphate Levels at the End of Treatment.
Time Frame: 6 weeks after baseline
6 weeks after baseline

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
Time Frame
Change From Baseline in Serum-phosphate Levels at Week 2
Time Frame: 2 weeks after baseline
2 weeks after baseline
Change From Baseline in Serum-phosphate Levels at Week 4
Time Frame: 4 weeks after baseline
4 weeks after baseline
Change From Baseline in Serum-phosphate Levels at Week 5
Time Frame: 5 weeks after baseline
5 weeks after baseline

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.
Vifor Pharma

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.
  • Principal Investigator: Prof. Rudolf P Wutrich, MD, Unafilliated

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

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.
December 1, 2008

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.
October 1, 2009

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.
March 1, 2010

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).
January 9, 2009

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.
January 14, 2009

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.
January 16, 2009

Study Record Updates

Last Update Posted (Estimate)

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 1, 2014

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.
March 3, 2014

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.
March 1, 2014

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.
  • PA-CL-03A
  • 75610

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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