| Trial ID: | L0471 |
| Source ID: | NCT01191762
|
| Associated Drug: |
Sevelamer Carbonate
|
| Title: |
Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01191762/results
|
| Conditions: |
Hyperparathyroidism|Chronic Kidney Disease
|
| Interventions: |
DRUG: sevelamer carbonate|DRUG: placebo
|
| Outcome Measures: |
Primary: Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate, This outcome measure documented the effect of intestinal phosphate-binding on \[PTH\]. Fractional change was calculated as (\[PTH\]post - \[PTH\]pre)/\[PTH\]pre, where 'pre' and 'post' referred respectively to baseline \[PTH\] (before treatment) and \[PTH\] after four weeks of treatment. Reductions were cited as negative numbers, and increments were cited as positive numbers., 4 weeks |
|
| Sponsor/Collaborators: |
Sponsor: Kenneth R. Phelps, M.D. | Collaborators: Genzyme, a Sanofi Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-04
|
| Completion Date: |
2013-04
|
| Results First Posted: |
2014-07-31
|
| Last Update Posted: |
2016-11-01
|
| Locations: |
Stratton Veterans Affairs Medical Center, Albany, New York, 12208, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01191762
|
