Dose Finding Study to Treat High Phosphate Levels in the Blood.

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ardelyx

Criteria

Inclusion Criteria:

1. Females and males aged ≥18 years

2. Chronic maintenance hemodialysis 3 x/week for a at least 3 months

3. Prescribed and taking at least 3 doses of phosphate binder per day

4. Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening

5. Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening

6. For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out

Exclusion Criteria:

1. Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.

2. Serum parathyroid hormone >1200 pg/mL

3. Significant metabolic acidosis

4. Clinical signs of hypovolemia at randomization

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