| Trial ID: | L0377 |
| Source ID: | NCT00889629
|
| Associated Drug: |
Doxercalciferol
|
| Title: |
Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Kidney Transplantation
|
| Interventions: |
DRUG: Doxercalciferol|DRUG: placebo|DRUG: 25-OH Vitamin D3
|
| Outcome Measures: |
Primary: - iPTH value of 100 pg/ml or lower, The number of patients achieving the target iPTH value of 100 pg/ml or lower measured. Change in the level of iPTH (baseline as compared with 3 and 6 months) using both absolute value and percent change from baseline., 6 months | Secondary: Change in 1,25 D2 and D3, 25-OH Vitamin D3 levels, The Change in the levels of 1,25 D2 and D3, 25-OH Vitamin D3 levels (baseline as compared with 3 month and end of study), 6 months|Change in FGF-23 levels, The Change in FGF-23 levels (baseline as compared with 3 and 6 months) were measured., 6 months|Change in serum bone turnover markers, The Change in the levels of serum osteocalcin, bone alkaline phosphatase and n-telopeptide of Type I collagen levels (baseline versus 3 and 6 months, 6 months|Change in Protein/creatinine ratio, Change in the level of Protein/creatinine ratio and or 24 hour urine for protein (baseline as compared with 3 and 6 months) 6. Change in the level of Protein/creatinine ratio (baseline as compared with 3 and 6 months) The Change in the level of Protein/creatinine ratio (baseline as compared with 3 and 6 months), 6 months
|
| Sponsor/Collaborators: |
Sponsor: Mariana Markell | Collaborators: Genzyme, a Sanofi Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
39
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-11
|
| Completion Date: |
2010-01
|
| Results First Posted: |
|
| Last Update Posted: |
2019-02-22
|
| Locations: |
SUNY Downstate Medical Center, Brooklyn, New York, 11234, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00889629
|
