Clinical trial NCT01464190: 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
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: 2011-11-03
Enrollment: 659
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 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.


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

Primary outcomes:
measure: Change From Baseline and Levels at Each Time Point for Serum Phosphorus
timeFrame: Every 4 weeks from baseline to Week 28
measure: Change From Baseline and Levels at Each Time Point for Serum Calcium
timeFrame: Every 4 weeks from baseline to Week 28
measure: Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
timeFrame: Every 4 weeks from baseline to Week 28
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
city: St. Pölten
country: Austria
facility: Medizinische Abteilung Nephrologie und Dialyse
city: Liege
country: Belgium
facility: CHU Sart Tilman
city: Rijeka
country: Croatia
facility: Clinical Hospital Center Rijeka
city: Novy Jicin
country: Czech Republic
facility: Hospital with Polyclinic Novy Jicin
city: Berlin
country: Germany
facility: KfH Nierenzentrum Berlin-Neukoelln
city: Valmiera
country: Latvia
facility: Vidzemes Hospital
city: Klaipeda
country: Lithuania
facility: JSC "Diaverum Clinics"
city: Lodz
country: Poland
facility: Teaching Hospital no.1 of Medical University of Lodz
city: Sibiu
country: Romania
facility: Dialmed Clinic SRL
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional hospital
city: Belgrade
country: Serbia
facility: Zvezdara Clinical Medical Center
city: Durban
country: South Africa
facility: St Augustines 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.