Study of Phosphate Levels in Patients With Chronic Kidney Disease (PA21)

An Open-label, Randomised, Active Controlled Multi-center Phase II Dose Finding Study to Evaluate the Ability of PA21 to Lower Serum Phosphate Levels and the Tolerability in Patients With Chronic Kidney Disease on Maintenance Hemodialysis

The purpose of this study is to investigate the ability of different doses of PA21 to lower serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: 1.25 g PA21 (250 mg iron); Drug: 5.0 g PA21 (1,000 mg iron); Drug: 7.5 g PA21 (1,500 mg iron); Drug: 10.0 g PA21 (2,000 mg iron); Drug: 12.5 g PA21 (2,500 mg iron); Drug: Sevelamer hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Gabrovo, Bulgaria, 5300
    • MHAT
  • Plovdiv, Bulgaria, 4003
    • MHAT Plovdiv
  • Ruse, Bulgaria, 7002
    • Department of Haemodialysis at MHAT
  • Sofia, Bulgaria, 1233
    • 5th MHAT Sofia
  • Sofia, Bulgaria, 1309
    • SHATCVD - National Cardiology Hospital
  • Sofia, Bulgaria, 1407
    • MHAT "Tokuda Hospital Sofia"
  • Sofia, Bulgaria, 1431
    • UMHAT "Alexandrovska" Dialysis Clinic
  • Sofia, Bulgaria, 1431
    • UMHAT "Sveti Ivan Rilski"
  • Sofia, Bulgaria, 1784
    • UMHAT "Sveta Anna"
  • Veliko Tarnovo, Bulgaria, 5000
    • MDHAT Department of Haemodialysis and Nephrology
• Croatia
  • Bjelovar, Croatia, 43000
    • Opca bonica Bjelovar
  • Karlovac, Croatia, 47000
    • Opca bolnica Karlovac
  • Koprivnica, Croatia, 48000
    • Opca bolnica
  • Osijek, Croatia, 31000
    • Klinicka bolnica Osijek
  • Rijeka, Croatia, 51000
    • Klinicki Bolnicki Centar Rijeka
  • Split, Croatia, 21000
    • Klinički Bolnički Centar Split
  • Zadar, Croatia, 23000
    • Opca bolnica Zadar
  • Zagreb, Croatia, 10000
    • Klinicka bolnica
  • Zagreb, Croatia, 10000
    • Poliklinika Sveti Duh II
  • Zagreb, Croatia, 10040
    • Klinicka bolnica Dubrava
• Czech Republic
  • Brno, Czech Republic, 60200
    • Innef a.s. Hemodialyzancni stredisko
  • Nove Město na Morave, Czech Republic, 59231
    • Nemocnice Nove Mesto na Morave
  • Novy Jicin, Czech Republic, 74101
    • Nemocnice s poliklinikou v Novem Jicine
  • Prague, Czech Republic, 2
    • Klinika nefrologie VFN
• Germany
  • Dortmund, Germany, 44263
    • Nephrologische Gemeinschaftspraxis und Dialysezentrum
  • Herne, Germany, 44625
    • Marienhospital
• Poland
  • Golub-Dobrzyń, Poland, 87-400
    • Niepubliczny Zaklad Opieki Zdrowotnej
  • Katowice, Poland, 40-027
    • Katedra i Klinika Nefrologii
  • Olkusz, Poland, 32-300
    • NZOZ Dializa
  • Poznań, Poland, 60-355
    • Katedra i Klinika Nefrologii
  • Siedlce, Poland, 26
    • Samodzielny Specjalistyczny
  • Sieradz, Poland, 98-200
    • Niepubliczny Zaklad Opieki Zdrowotnej
  • Warszawa, Poland, 01-809
    • Centrum Dializy i Diagnostyki
• Romania
  • Bucuresti, Romania, 050098
    • Spitalul Universitar de Urgență București
  • Bucuresti, Romania, 022328
    • Institutul Clinic Fundeni
  • Lasi, Romania, 700503
    • Spitalul Clinic
  • Oradea, Romania, 410562
    • SC Renamed Nefrodial SRL
  • Targu Mures, Romania, 540136
    • S.C. Avitum S.R.L
• Russian Federation
  • Kazan, Russian Federation, 420064
    • GOU VPO Kazan
  • Moscow, Russian Federation, 125284
    • GUZ City Clinical Hospital
  • Novosibirsk, Russian Federation, 630120
    • MUZ City Clinical Hospital
  • Smolensk, Russian Federation, 214001
    • MLPU Clinical City Hospital
  • St. Petersburg, Russian Federation, 191104
    • Saint-Petersburg CUS City Mariinskaya Hospital
  • St. Petersburg, Russian Federation, 195257
    • Saint-Petersburg GUZ City Clinical Hospital
  • St. Petersburg, Russian Federation, 195607
    • GOU VPO
  • St. Petersburg, Russian Federation, 196247
    • Saint-Petersburg GUZ City Hospital
  • St. Petersburg, Russian Federation, 197089
    • GOU VPO
  • St.Petersburg, Russian Federation, 198205
    • CUS City Hospital
• Switzerland
  • Aarau, Switzerland, 5001
    • Kantonspital Aarau
  • Lausanne, Switzerland, 1011
    • CHUV Lausanne
  • Zürich, Switzerland, 8091
    • UniversitätsSpital Zürich
• United States
  • Colorado
    • Arvada, Colorado, United States, 80002
      • Western Nephrology & Metabolic Disease
    • Denver, Colorado, United States, 80220
      • Complete Renal Care
  • Florida
    • Pembroke Pines, Florida, United States, 33028
      • Pines Clinical Research
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • New York
    • Fresh Meadows, New York, United States, 11365
      • Nephrology Associates
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals / Case Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Southeast Renal Research Institute
    • Nashville, Tennessee, United States, 37205
      • Nephrology Associates
  • Texas
    • Houston, Texas, United States, 77099
      • Southwest Houston Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main Inclusion Criteria:

• ≥ 18 years of age,
• Receiving stable maintenance hemodialysis 3 times a week
• On restricted phosphate diet at screening and throughout study
• Receiving stable dose of phosphate binder for at least 1 month
• Serum phosphate levels >1.78 mmol/L

Main Exclusion Criteria:

• Uncontrolled hyperphosphatemia
• Hypercalcemia at screening or during washout
• Serum calcium < 1.9 mmol/L (<7.6 mg/dL)
• Severe hyperparathyroidism (iPTH levels >600 ng/L)
• Pregnancy or lactation
• Iron deficiency anemia
• History of hemochromatosis or ferritin >800 mg/L,
• Hepatitis B, hepatitis C or other significant concurrent liver disorders
• Known positivity to HIV
• Use of oral iron preparations 1 month before screening,
• Serious medical condition or uncontrolled systemic disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1.25 g PA21	Drug: 1.25 g PA21 (250 mg iron); Daily dose of 1.25 g PA21 (1 tablet/day) for 6 weeks. One PA21 tablet will be taken orally with the largest meal of the day.
Experimental: 5.0 g PA21	Drug: 5.0 g PA21 (1,000 mg iron); Daily dose of 5.0 g PA21 (4 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with the largest meal of the day, and one PA21 tablet will be taken orally with each of the two smaller main meals of the day (3 meals per day).
Experimental: 7.5 g PA21	Drug: 7.5 g PA21 (1,500 mg iron); Daily dose of 7.5 g PA21 (6 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with each of the three main meals of the day (3 meals per day).
Experimental: 10.0 g PA21	Drug: 10.0 g PA21 (2,000 mg iron); Daily dose of 10.0 g PA21 (8 tablets/day) for 6 weeks. Four PA21 tablets will be taken orally with the largest meal of the day, and two PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
Experimental: 12.5 g PA21	Drug: 12.5 g PA21 (2,500 mg iron); Daily dose of 12.5 g PA21 (10 tablets/day) for 6 weeks. Four tablets will be taken orally with the largest meal of the day, and three PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
Experimental: Sevelamer hydrochloride - active control	Drug: Sevelamer hydrochloride; Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets/day) for 6 weeks. Two Sevelamer tablets will be taken orally with each of the three main meals of the day (3 meals per day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Serum-phosphate Levels at the End of Treatment.	6 weeks after baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Serum-phosphate Levels at Week 2	2 weeks after baseline
Change From Baseline in Serum-phosphate Levels at Week 4	4 weeks after baseline
Change From Baseline in Serum-phosphate Levels at Week 5	5 weeks after baseline

Collaborators and Investigators

• Sponsor: Vifor Pharma
• Investigators: Principal Investigator: Prof. Rudolf P Wutrich, MD, Unafilliated

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: January 9, 2009
• First Submitted That Met QC Criteria: January 14, 2009
• First Posted (Estimate): January 16, 2009

Study Record Updates

• Last Update Posted (Estimate): April 1, 2014
• Last Update Submitted That Met QC Criteria: March 3, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Hemodialysis
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Trace Elements; Micronutrients; Chelating Agents; Sequestering Agents; Sevelamer; Iron
• Other Study ID Numbers: PA-CL-03A; 75610