NCT01324128

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,059

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2011

Geographic Reach
15 countries

15 active sites

Status
completed

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

March 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 1, 2014

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

1.1 years

First QC Date

March 24, 2011

Results QC Date

December 20, 2013

Last Update Submit

April 3, 2014

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

PA21Phosphate Binder

Outcome Measures

Primary Outcomes (1)

  • 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

    Week 24, Week 27

Secondary Outcomes (1)

  • Change in Serum Phosphorus Levels From Baseline to Week 12

    Week 12 post Baseline

Study Arms (3)

PA21 (2.5 g tablet)

EXPERIMENTAL
Drug: PA21 (2.5 g tablet containing 500 mg iron)

Sevelamer carbonate

ACTIVE COMPARATOR
Drug: Sevelamer carbonate

PA21-1 (1.25 g tablet)

OTHER
Drug: PA21-1 (1.25 g tablet containing 250 mg iron)

Interventions

PA21 (2.5 g tablet containing 500 mg iron)DRUG

Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).

PA21 (2.5 g tablet)
Sevelamer carbonateDRUG

Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)

Sevelamer carbonate
PA21-1 (1.25 g tablet containing 250 mg iron)DRUG

Low dose comparator (1.25 g/day)

PA21-1 (1.25 g tablet)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Study Sites (15)

Unknown Facility

San Antonio, Texas, 78215, United States

Location

LKH St. Polten

Sankt Pölten, 3100, Austria

Location

CHU Sart Tilman

Liège, 4000, Belgium

Location

Clinical Hospital Center Rijeka

Rijeka, 51000, Croatia

Location

Dialysis Centre Fresenius Medical Care

Sokolov, 35601, Czechia

Location

KfH Nierenzentrum Berlin-Neukoelln

Berlin, 12045, Germany

Location

Vidzemes Hospital

Valmiera, LV-4201, Latvia

Location

Vilnius University Hospital Santariskiu Clinics

Vilnius, LT-08661, Lithuania

Location

Teaching Hospital no.1 of Medical University of Lodz

Lodz, 90-153, Poland

Location

Dialmed Clinic SRL

Sibiu, 550135, Romania

Location

City Mariinsky Hospital

Saint Petersburg, 191104, Russia

Location

Zvezdara Clinical Medical Center

Belgrade, 11000, Serbia

Location

Lakeview Hospital

Benoni, 1500, South Africa

Location

Mykolayiv Regional Hospital

Mykolayiv, 54058, Ukraine

Location

Dorset County Hospital NHS Foundation Trust

Dorset, DT1 2JY, United Kingdom

Location

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: 40576086DERIVED

  • 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.

    PMID: 29656600DERIVED

MeSH Terms

Interventions

IronSevelamer

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsPolyaminesAminesOrganic Chemicals

Results Point of Contact

Title
Medical Information
Organization
Vifor Pharma
medinfo@viforpharma.com
41 58 851 8222

Study Officials

  • Juergen Floege, MD

    Medizinische Klinik II

    PRINCIPAL INVESTIGATOR

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

March 24, 2011

First Posted

March 28, 2011

Study Start

March 1, 2011

Primary Completion

April 1, 2012

Study Completion

October 1, 2012

Last Updated

April 24, 2014

Results First Posted

April 1, 2014

Record last verified: 2014-04

Locations

UA(1)LA(1)PL(1)BE(1)SE(1)RO(1)LI(1)ZA(1)CR(1)AU(1)RU(1)GB(1)CZ(1)DE(1)US(1)