NCT02081534

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

A Phase 2b, Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicentre Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of AZD1722 to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Ardelyx · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The study consists of a screening period of approximately 1 week, a wash out period of up to 3 weeks, where existing phosphate lowering medication is withheld, a 4-week treatment period and a follow-up period of up to 2 weeks, during which patients are put back on their pre washout phosphate lowering medication. The wash out period will be either 1 week, 2 weeks or 3 weeks depending on the increase in s-phosphate levels. There are 7 parallel treatment arms in the study with bid and od treatment regimens. Laboratory efficacy endpoints and safety assessments will be evaluated at various times throughout the study. The target population of the study is: male or female patients, above18 years of age with End Stage Renal Disease (ESRD) on chronic maintenance hemodialysis (HD) 3 times a week for a minimum of 3 months.

Conditions

• Hyperphosphatemia

Interventions

Type	Name	Description
DRUG	AZD1722	AZD1722, oral tablet
DRUG	Placebo	Placebo bid, double dummy technique

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-03-07
• Last updated: 2020-09-14
• Results posted: 2020-09-14

Locations

41 sites across 4 countries: United States, Poland, Slovakia, United Kingdom