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Completed

NCT Number: NCT00824460

Study of Phosphate Levels in Patients With Chronic Kidney Disease

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MHAT, Gabrovo, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1.25 g PA21 (250 mg iron)

Drug

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.

5.0 g PA21 (1,000 mg iron)

Drug

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).

7.5 g PA21 (1,500 mg iron)

Drug

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).

10.0 g PA21 (2,000 mg iron)

Drug

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).

12.5 g PA21 (2,500 mg iron)

Drug

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).

Sevelamer Hydrochloride

Drug

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 outcomes

  1. Change From Baseline in Serum-phosphate Levels at the End of Treatment.

    Time frame: 6 weeks after baseline

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vifor Pharma

Industry

Registry information

Official study 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

Acronym: PA21

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jan 16, 2009
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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