| Trial ID: | L1229 |
| Source ID: | NCT01764854
|
| Associated Drug: |
Azd1722 (In-Patient)
|
| Title: |
Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01764854/results
|
| Conditions: |
End Stage Renal Disease|Chronic Kidney Disease Stage 5|ESRD
|
| Interventions: |
DRUG: AZD1722 (in-patient)|DRUG: Placebo (in-patient)|DRUG: AZD1722 (out-patient)|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Mean Weekly Interdialytic Weight Gain (IDWG), Patients are weighed pre dialysis prior to their first dialysis of the week. This measure looks at the change in pre-dialysis weight over time, Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment) | Secondary: Stool Sodium Content, The amount of sodium in a days worth of stool output, Days 1 through 7
|
| Sponsor/Collaborators: |
Sponsor: Ardelyx | Collaborators: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
88
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-01
|
| Completion Date: |
2013-10
|
| Results First Posted: |
2020-08-10
|
| Last Update Posted: |
2020-08-10
|
| Locations: |
Southwest Clinical Research Institute, Tempe, Arizona, 85284, United States|Denver Nephrology, Denver, Colorado, 80230, United States|DaVita Clinical Research, Minneapolis, Minnesota, 55404, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01764854
|
