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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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-

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

Detailed Summary:

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.


Sponsor: Ardelyx

Current Primary Outcome: Change in serum phosphate levels [ Time Frame: End of wash out (pre randomization value) to end of treatment (Day 29) ]

Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The number of patients reaching S-phosphate goal [ Time Frame: End of wash out (pre randomization value) to end of treatment (Day 29) ]
    Comparison of the effect of AZD1722 versus placebo on the number of patients reaching serum phosphate goal levels defined as < 5.5 mg/dl (1.78 mmol/L) during 4 weeks of treatment
  • Change from baseline in calcium x phosphorus product [ Time Frame: End of wash out (pre randomization value) to end of treatment (Day 29) ]
    Change from baseline (end of wash out) in calcium x phosphorus product
  • Change from pre wash out in S-phosphate levels [ Time Frame: Pre wash out to end of treatment (Day 29) ]
    Comparison of the effect of AZD1722 versus pre wash out phosphate-lowering treatment, by comparing serum phosphate levels during AZD1722 treatment to pre wash out levels
  • Safety and tolerability of AZD1722 [ Time Frame: End of wash out (pre randomization value) to end of treatment (Day 29) ]
    To evaluate the safety and tolerability of AZD1722 as assessed by adverse event recording, vital signs, 12-lead electrocardiogram, physical examination, and safety laboratory monitoring
  • Dose response relationship [ Time Frame: End of wash out (pre randomization value) to end of treatment (Day 29) ]
    To characterize the dose response relationship of AZD1722 on serum phosphate levels


Original Secondary Outcome: Same as current

Information By: Ardelyx

Dates:
Date Received: March 6, 2014
Date Started: March 2014
Date Completion:
Last Updated: September 18, 2015
Last Verified: September 2015