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A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients

Primary Purpose

Chronic Kidney Disease Requiring Chronic Dialysis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PA21 (2.5 g tablet containing 500 mg iron)
Sevelamer carbonate
Sponsored by
Vifor Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease Requiring Chronic Dialysis focused on measuring PA21, Phosphate Binder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who have completed treatment in Protocol PA-CL-05A
  • Written Informed Consent

Exclusion Criteria:

  • Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
  • Other significant medical conditions
  • Pregnancy

Sites / Locations

  • Medizinische Abteilung Nephrologie und Dialyse
  • CHU Sart Tilman
  • Clinical Hospital Center Rijeka
  • Hospital with Polyclinic Novy Jicin
  • KfH Nierenzentrum Berlin-Neukoelln
  • Vidzemes Hospital
  • JSC "Diaverum Clinics"
  • Teaching Hospital no.1 of Medical University of Lodz
  • Dialmed Clinic SRL
  • Kemerovo Regional hospital
  • Zvezdara Clinical Medical Center
  • St Augustines Hospital
  • Mykolayiv Regional Hospital
  • Dorset County Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PA21

Sevelamer carbonate

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2011
Last Updated
March 3, 2014
Sponsor
Vifor Pharma
Collaborators
Fresenius Medical Care North America
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1. Study Identification

Unique Protocol Identification Number
NCT01464190
Brief Title
A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vifor Pharma
Collaborators
Fresenius Medical Care North America

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Requiring Chronic Dialysis
Keywords
PA21, Phosphate Binder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
659 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PA21
Arm Type
Experimental
Arm Title
Sevelamer carbonate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PA21 (2.5 g tablet containing 500 mg iron)
Intervention Description
Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
Intervention Type
Drug
Intervention Name(s)
Sevelamer carbonate
Intervention Description
Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
Primary Outcome Measure Information:
Title
Change From Baseline and Levels at Each Time Point for Serum Phosphorus
Description
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Time Frame
Every 4 weeks from baseline to Week 28
Title
Change From Baseline and Levels at Each Time Point for Serum Calcium
Description
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Time Frame
Every 4 weeks from baseline to Week 28
Title
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
Description
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Time Frame
Every 4 weeks from baseline to Week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who have completed treatment in Protocol PA-CL-05A Written Informed Consent Exclusion Criteria: Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH) Other significant medical conditions Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juergen Floege, MD
Organizational Affiliation
Medizinische Klinik II
Official's Role
Principal Investigator
Facility Information:
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Medizinische Abteilung Nephrologie und Dialyse
City
St. Pölten
ZIP/Postal Code
3100
Country
Austria
Facility Name
CHU Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Clinical Hospital Center Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Hospital with Polyclinic Novy Jicin
City
Novy Jicin
ZIP/Postal Code
74101
Country
Czech Republic
Facility Name
KfH Nierenzentrum Berlin-Neukoelln
City
Berlin
ZIP/Postal Code
12045
Country
Germany
Facility Name
Vidzemes Hospital
City
Valmiera
ZIP/Postal Code
LV-4201
Country
Latvia
Facility Name
JSC "Diaverum Clinics"
City
Klaipeda
ZIP/Postal Code
LT-93220
Country
Lithuania
Facility Name
Teaching Hospital no.1 of Medical University of Lodz
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Dialmed Clinic SRL
City
Sibiu
ZIP/Postal Code
550135
Country
Romania
Facility Name
Kemerovo Regional hospital
City
Kemerovo
ZIP/Postal Code
650029
Country
Russian Federation
Facility Name
Zvezdara Clinical Medical Center
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
St Augustines Hospital
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Mykolayiv Regional Hospital
City
Mykolayiv
ZIP/Postal Code
54058
Country
Ukraine
Facility Name
Dorset County Hospital NHS Foundation Trust
City
Dorset
ZIP/Postal Code
DT1 2JY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29656600
Citation
Sprague 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.
Results Reference
derived

Learn more about this trial

A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients

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