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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00824460
Recruitment Status : Completed
First Posted : January 16, 2009
Results First Posted : April 1, 2014
Last Update Posted : April 1, 2014
Sponsor:
Information provided by (Responsible Party):
Vifor Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Kidney Disease 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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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).




Primary Outcome Measures :
  1. Change From Baseline in Serum-phosphate Levels at the End of Treatment. [ Time Frame: 6 weeks after baseline ]

Secondary Outcome Measures :
  1. Change From Baseline in Serum-phosphate Levels at Week 2 [ Time Frame: 2 weeks after baseline ]
  2. Change From Baseline in Serum-phosphate Levels at Week 4 [ Time Frame: 4 weeks after baseline ]
  3. Change From Baseline in Serum-phosphate Levels at Week 5 [ Time Frame: 5 weeks after baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824460


Locations
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Sponsors and Collaborators
Vifor Inc.
Investigators
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Principal Investigator: Prof. Rudolf P Wutrich, MD Unafilliated

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Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT00824460    
Other Study ID Numbers: PA-CL-03A
75610
First Posted: January 16, 2009    Key Record Dates
Results First Posted: April 1, 2014
Last Update Posted: April 1, 2014
Last Verified: March 2014
Keywords provided by Vifor Inc.:
Hemodialysis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Iron
Sevelamer
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action