A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients
An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Phase 3 Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21 Compared With Sevelamer Carbonate in Dialysis Patients With Hyperphosphataemia. Extension Study for Protocol PA-CL-05A (NCT01324128)
1 other identifier
interventional
659
15 countries
15
Brief Summary
This is a Phase 3, randomised, active controlled, multicentre extension study to investigate the long-term safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. This is an extension study to PA-CL-05A (NCT01324128), subjects have already been enrolled and have been treated with study medication for at least 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2011
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 12, 2011
CompletedFirst Posted
Study publicly available on registry
November 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
February 17, 2014
CompletedApril 1, 2014
March 1, 2014
1.1 years
September 12, 2011
December 20, 2013
March 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change From Baseline and Levels at Each Time Point for Serum Phosphorus
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Every 4 weeks from baseline to Week 28
Change From Baseline and Levels at Each Time Point for Serum Calcium
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Every 4 weeks from baseline to Week 28
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Every 4 weeks from baseline to Week 28
Study Arms (2)
PA21
EXPERIMENTALSevelamer carbonate
ACTIVE COMPARATORInterventions
Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
Eligibility Criteria
You may qualify if:
- Subjects who have completed treatment in Protocol PA-CL-05A
- Written Informed Consent
You may not qualify if:
- Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
- Other significant medical conditions
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vifor Pharmalead
- Fresenius Medical Care North Americacollaborator
Study Sites (15)
Unknown Facility
San Antonio, Texas, 78215, United States
Medizinische Abteilung Nephrologie und Dialyse
Sankt Pölten, 3100, Austria
CHU Sart Tilman
Liège, 4000, Belgium
Clinical Hospital Center Rijeka
Rijeka, 51000, Croatia
Hospital with Polyclinic Novy Jicin
Nový Jičín, 74101, Czechia
KfH Nierenzentrum Berlin-Neukoelln
Berlin, 12045, Germany
Vidzemes Hospital
Valmiera, LV-4201, Latvia
JSC "Diaverum Clinics"
Klaipėda, LT-93220, Lithuania
Teaching Hospital no.1 of Medical University of Lodz
Lodz, 90-153, Poland
Dialmed Clinic SRL
Sibiu, 550135, Romania
Kemerovo Regional hospital
Kemerovo, 650029, Russia
Zvezdara Clinical Medical Center
Belgrade, 11000, Serbia
St Augustines Hospital
Durban, 4001, South Africa
Mykolayiv Regional Hospital
Mykolayiv, 54058, Ukraine
Dorset County Hospital NHS Foundation Trust
Dorset, DT1 2JY, United Kingdom
Related Publications (2)
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVEDSprague SM, Ketteler M, Covic AC, Floege J, Rakov V, Walpen S, Rastogi A. Long-term efficacy and safety of sucroferric oxyhydroxide in African American dialysis patients. Hemodial Int. 2018 Oct;22(4):480-491. doi: 10.1111/hdi.12663. Epub 2018 Apr 15.
PMID: 29656600DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information
- Organization
- Vifor Pharma
Study Officials
- PRINCIPAL INVESTIGATOR
Juergen Floege, MD
Medizinische Klinik II
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2011
First Posted
November 3, 2011
Study Start
September 1, 2011
Primary Completion
October 1, 2012
Study Completion
April 1, 2013
Last Updated
April 1, 2014
Results First Posted
February 17, 2014
Record last verified: 2014-03