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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT00824460
First received: January 9, 2009
Last updated: August 15, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
 Drug: 1.25g PA21
Drug: 5.0g PA21
Drug: 7.5g PA21
Drug: 10.0g PA21
Drug: 12.5 g PA21
Drug: Sevelamer hydrochloride
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • Change from baseline in serum-phosphate levels at the end of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in serum-phosphate levels at week 2 [ Time Frame: 2 weeks after baseline ] [ Designated as safety issue: No ]
  • Change from baseline in serum-phosphate levels at week 4 [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]
  • Change from baseline in serum-phosphate levels at week 5 [ Time Frame: 5 weeks after baseline ] [ Designated as safety issue: No ]

Enrollment: 154
Study Start Date: December 2008
Study Completion Date: March 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.25 g PA21
Daily dose of 1.25g PA21 (1 tablet)
 Drug: 1.25g PA21
Daily dose of 1.25g PA21 (1 PA21 tablet per day) for 6 weeks. One PA21 tablet will be taken orally with the largest meal of the day.
Experimental: 5.0g PA21
Daily dose of 5.0g PA21 (4 tablets)
 Drug: 5.0g PA21
Daily dose of 5.0g PA21 (4 PA21 tablets per 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
Daily dose of 7.5g PA21 (6 tablets)
 Drug: 7.5g PA21
Daily dose of 7.5g PA21 (6 PA21 tablets per 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
Daily dose of 10.0g PA21 (8 tablets)
 Drug: 10.0g PA21
Daily dose of 10.0 g PA21 (8 PA21 tablets per 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: 12.5g PA21
Daily dose of 12.5g PA21 (10 tablets)
 Drug: 12.5 g PA21
Daily dose of 12.5 g PA21 (10 tablets per 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: active control
Daily dose of 4.8g sevelamer hydrochloride (6 tablets)
 Drug: Sevelamer hydrochloride
Sevelamer hydrochloride 4.8 g/day (6 tablets per 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).
Other Name: Renagel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824460

  Show 64 Study Locations
Sponsors and Collaborators
Vifor Inc.
Investigators
Principal Investigator: Prof. Rudolf P Wutrich, MD Unafilliated
  More Information

No publications provided

Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT00824460     History of Changes
Other Study ID Numbers: PA-CL-03A, 75610
Study First Received: January 9, 2009
Last Updated: August 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Vifor Inc.:
Hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
 Sevelamer
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013