Clinical trial NCT01324128: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: PA21
Phosphate Binder
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
Collaborators: name: Fresenius Medical Care North America
First posted: 2011-03-28
Enrollment: 1059
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Serum Phosphorus Levels From Week 24 to Week 27
timeFrame: Week 24, Week 27
Secondary outcomes:
measure: Change in Serum Phosphorus Levels From Baseline to Week 12
timeFrame: Week 12 post Baseline
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
city: St. Polten
country: Austria
facility: LKH St. Polten
city: Liege
country: Belgium
facility: CHU Sart Tilman
city: Rijeka
country: Croatia
facility: Clinical Hospital Center Rijeka
city: Sokolov
country: Czech Republic
facility: Dialysis Centre Fresenius Medical Care
city: Berlin
country: Germany
facility: KfH Nierenzentrum Berlin-Neukoelln
city: Valmiera
country: Latvia
facility: Vidzemes Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinics
city: Lodz
country: Poland
facility: Teaching Hospital no.1 of Medical University of Lodz
city: Sibiu
country: Romania
facility: Dialmed Clinic SRL
city: St. Petersburg
country: Russian Federation
facility: City Mariinsky Hospital
city: Belgrade
country: Serbia
facility: Zvezdara Clinical Medical Center
city: Benoni
country: South Africa
facility: Lakeview Hospital
city: Mykolayiv
country: Ukraine
facility: Mykolayiv Regional Hospital
city: Dorset
country: United Kingdom
facility: Dorset County Hospital NHS Foundation Trust
Study officials:
affiliation: Medizinische Klinik II
name: Juergen Floege, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.