Study of Phosphate Levels in Patients With Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.25 g PA21<br> | Drug: 1.25 g PA21 (250 mg iron)<br>* 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.<br>|
| Experimental: 5.0 g PA21<br> | Drug: 5.0 g PA21 (1,000 mg iron)<br>* 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).<br>|
| Experimental: 7.5 g PA21<br> | Drug: 7.5 g PA21 (1,500 mg iron)<br>* 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).<br>|
| Experimental: 10.0 g PA21<br> | Drug: 10.0 g PA21 (2,000 mg iron)<br>* 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).<br>|
| Experimental: 12.5 g PA21<br> | Drug: 12.5 g PA21 (2,500 mg iron)<br>* 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).<br>|
| Experimental: Sevelamer hydrochloride - active control<br> | Drug: Sevelamer hydrochloride<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis