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A Phase 3 Study to Investigate the Safety 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
PA21-1 (1.25 g tablet containing 250 mg iron)
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:

  • Dialysis patients with hyperphosphataemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL)
  • Stable dose of phosphate binder
  • Written informed consent

Exclusion Criteria:

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

Sites / Locations

  • LKH St. Polten
  • CHU Sart Tilman
  • Clinical Hospital Center Rijeka
  • Dialysis Centre Fresenius Medical Care
  • KfH Nierenzentrum Berlin-Neukoelln
  • Vidzemes Hospital
  • Vilnius University Hospital Santariskiu Clinics
  • Teaching Hospital no.1 of Medical University of Lodz
  • Dialmed Clinic SRL
  • City Mariinsky Hospital
  • Zvezdara Clinical Medical Center
  • Lakeview Hospital
  • Mykolayiv Regional Hospital
  • Dorset County Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

PA21 (2.5 g tablet)

Sevelamer carbonate

PA21-1 (1.25 g tablet)

Arm Description

Outcomes

Primary Outcome Measures

Change in Serum Phosphorus Levels From Week 24 to Week 27
Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27

Secondary Outcome Measures

Change in Serum Phosphorus Levels From Baseline to Week 12
Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group.

Full Information

First Posted
March 24, 2011
Last Updated
April 3, 2014
Sponsor
Vifor Pharma
Collaborators
Fresenius Medical Care North America
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1. Study Identification

Unique Protocol Identification Number
NCT01324128
Brief Title
A Phase 3 Study to Investigate the Safety 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 Safety and Efficacy of PA21 Compared With Sevelamer Carbonate Followed by a Randomised Comparison of PA21 Maintenance Dose Versus PA21-Low Dose in Dialysis Patients With Hyperphosphataemia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
October 2012 (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 study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.

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
1059 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PA21 (2.5 g tablet)
Arm Type
Experimental
Arm Title
Sevelamer carbonate
Arm Type
Active Comparator
Arm Title
PA21-1 (1.25 g tablet)
Arm Type
Other
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
Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)
Intervention Type
Drug
Intervention Name(s)
PA21-1 (1.25 g tablet containing 250 mg iron)
Intervention Description
Low dose comparator (1.25 g/day)
Primary Outcome Measure Information:
Title
Change in Serum Phosphorus Levels From Week 24 to Week 27
Description
Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27
Time Frame
Week 24, Week 27
Secondary Outcome Measure Information:
Title
Change in Serum Phosphorus Levels From Baseline to Week 12
Description
Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group.
Time Frame
Week 12 post Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dialysis patients with hyperphosphataemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL) Stable dose of phosphate binder 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
LKH St. Polten
City
St. Polten
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
Dialysis Centre Fresenius Medical Care
City
Sokolov
ZIP/Postal Code
35601
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
Vilnius University Hospital Santariskiu Clinics
City
Vilnius
ZIP/Postal Code
LT-08661
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
City Mariinsky Hospital
City
St. Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Zvezdara Clinical Medical Center
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Lakeview Hospital
City
Benoni
ZIP/Postal Code
1500
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
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A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients

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