Study to evaluate doses of AZD1722 to be used for the treatment of high phosphate levels in the blood in patients with severe kidney disease.

• Conditions: Hyperphosphatemia in patients with end-stage renal disease on hemodialysis.; MedDRA version: 16.1Level: LLTClassification code 10020712Term: HyperphosphatemiaSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2013-004319-33-SK
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-23
• Last Update Posted: 19 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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 (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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1. Severe hyperphosphatemia defined as >10 mg/dL (3.23 mmol/L) on Phosphate-binders repeatedly during clinical routine monitoring for the 3 preceding months before screening visit
2. Serum parathyroid hormone >1200 pg/mL
3. Significant metabolic acidosis defined as serum bicarbonate <18 mmol/L at last visit prior to randomization, analyzed at the central lab used in the study.
4. Clinical signs of hypovolemia at randomization as judged by the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified