| Trial ID: | L0321 |
| Source ID: | NCT01128179
|
| Associated Drug: |
Lanthanum Carbonate
|
| Title: |
Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01128179/results
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: Lanthanum carbonate|DRUG: Placebo
|
| Outcome Measures: |
Primary: Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF), FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels., 12 Weeks | Secondary: Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF), 12 Weeks|Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF), 12 weeks|Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF), 12 weeks|Change From Baseline in Serum Phosphate Values at Week 12 (LOCF), 12 weeks|Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF), 12 weeks|Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF), 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Shire
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
35
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-12-06
|
| Completion Date: |
2012-04-16
|
| Results First Posted: |
2013-05-22
|
| Last Update Posted: |
2021-06-09
|
| Locations: |
Dr Pablo Urena Torres, Saint Ouen, Paris, 93400, France
|
| URL: |
https://clinicaltrials.gov/show/NCT01128179
|
