Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03824587|
Recruitment Status : Active, not recruiting
First Posted : January 31, 2019
Last Update Posted : June 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hyperphosphatemia||Drug: Tenapanor Drug: Placebo||Phase 2 Phase 3|
The study consists of a Screening visit; a Run-in Period of at least 2 weeks and up to 4 weeks, where existing phosphate binder treatment is maintained; and a 4-week Double-Blind Treatment Period.
At Screening, a subject must be on thrice daily phosphate binder therapy and have a serum phosphate (s-P) level ≥5.5 and ≤10.0 mg/dL to qualify for entering the study. s-P will be measured at each visit during the run-in period to enable the evaluation of the s-P randomization criteria.
Subjects who qualify to enroll in the study will be randomized in a 1:1 ratio to receive tenapanor or placebo while continuing their existing phosphate binder treatment.
During the Double-Blind Treatment Period, subjects will receive tenapanor or placebo starting at a dose of 30 mg bid
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||214 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy in End-Stage Renal Disease (ESRD) Subjects With Hyperphosphatemia|
|Actual Study Start Date :||February 28, 2019|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: Tenapanor 30 mg BID
During the Double-Blind Treatment Period, subjects will receive tenapanor or placebo starting at a dose of 30 mg bid (three 10 mg tablets each time).
Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period.
|Placebo Comparator: Placebo||
- Change in serum phosphorus (s-P) level from baseline and at Week 4. [ Time Frame: 4 Weeks (28 days randomization period) ]Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups.
- s-P response at Week 4 [ Time Frame: 4 Weeks (28 days randomization period) ]Achieving an s-P level <5.5 mg/dL
- Relative change from baseline in iFGF23 at Week 4 [ Time Frame: 4 Weeks (28 days randomization period) ]iFGF23 at Week 4/baseline iFGF23 - 1
- Relative change from baseline in cFGF23 at Week 4 [ Time Frame: 4 Weeks (28 days randomization period) ]cFGF23 at Week 4/baseline cFGF23 - 1
- Change from baseline in s-P level at Week 1, Week 2, and Week 3 [ Time Frame: 4 weeks ]serum phosphorus change
- s-P response at Week 1, Week 2, and Week 3 [ Time Frame: 4 weeks ]number of patients with serum phosphorus below 5.5 mg/dL
- Change from baseline in PTH at Week 4 [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824587
Show 48 Study Locations
|Study Chair:||David P Rosenbaum, PhD||Ardelyx|