Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients
Recruitment status was Recruiting
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Purpose
People with kidney transplants often develop bone disease. One reason for bone disease may be overactivity of a gland in the neck called the parathyroid gland. Overactivity of the parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been discovered that many patients with kidney transplants have low Vitamin D levels. The investigators are examining the effects of doxercalciferol on parathyroid hormone levels, proteinuria and bone turnover markers in people who have had a kidney transplant.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Kidney Disease Kidney Transplantation |
Drug: Doxercalciferol Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pilot Study: Effects of Hectorol (Doxercalciferol) Vitamin D Replacement on Proteinuria, PTH Level and Bone Turnover in Stable Kidney Transplant Recipients: a Single-Blind, Placebo-Controlled Study in Patients Receiving 25-OH Vitamin D3 |
- Number of patients achieving the target iPTH value of 100 pg/ml or lower [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in 1,25 D2 and D3, 25-OH Vitamin D3 levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- iPTH at baseline, 1, 3 and 6 months (absolute value and percent change from baseline) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in FGF-23 levels at baseline, 1, 3 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in serum bone turnover markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in Protein/creatinine ratio and/or 24 hour urine for protein at baseline, 1, 3 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Hectorol plus 25-OH Vitamin D3
|
Drug: Doxercalciferol
1 mcg qd then uptitrated as specified in protocol
Other Name: Hectorol
|
|
Placebo Comparator: 2
placebo plus 25-OH Vitamin D3
|
Drug: placebo
placebo of doxercalciferol
|
Detailed Description:
People with kidney transplants often develop bone disease. One reason for bone disease may be overactivity of a gland in the neck called the parathyroid gland. Overactivity of the parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been discovered that many patients with kidney transplants have low Vitamin D levels.
25-OH Vitamin D3 is now recommended to treat kidney transplant patients with low vitamin D levels but it may not be enough to treat the parathyroid problems and bone disease. Doxercalciferol is a form of Vitamin D that has been used to treat bone disease and parathyroid problems in dialysis patients but has not yet been studied in patients with kidney transplants. We are interested in seeing whether doxercalciferol given together with 25-OH Vitamin D3 will be a better treatment for the overactive parathyroid gland and bone disease than 25-OH Vitamin D3 alone in patients with kidney transplants.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults of both genders between the ages of 18 and 65.
- Kidney transplant at least 1 year prior to enrollment
- Creatinine value of <2.5 mg/dl with no excursion >0.5 within the past 3 months
- Proteinuria of 500 mg/24 hours or a protein/creatinine ratio of 0.5 or greater
- Hypovitaminosis D, as defined by a 25-OH Vitamin D value of <25 ng/ml
- Intact PTH value between 150 and 600 pg/ml
Exclusion Criteria:
- History of parathyroidectomy
- History of prior intolerance to vitamin D therapy (not including hypercalcemia)
- History of biopsy proven acute rejection over the 3 months preceding enrollment
- Recent (over the past month) addition of an ACE inhibitor or Angiotensin -
- Receptor Blocking agent - patients who have been on a stable dose are acceptable
- Current use of active Vitamin D supplement (patients in whom therapy has been discontinued more than 1 month prior to enrollment are acceptable)
- Postmenopausal woman or women receiving hormone replacement therapy
Contacts and Locations| United States, New York | |
| SUNY Downstate Medical Center | Recruiting |
| Brooklyn, New York, United States, 11234 | |
| Contact: Sima Terebelo, MPH, RPA-C 718-270-8216 | |
| Principal Investigator: Mariana Markell, MD | |
| Sub-Investigator: Sima Terebelo, MPH, RPA-C | |
| Principal Investigator: | Mariana Markell, MD | State University of New York - Downstate Medical Center |
More Information
No publications provided
| Responsible Party: | Dr Mariana Markell, SUNY Downstate Medical Center |
| ClinicalTrials.gov Identifier: | NCT00889629 History of Changes |
| Other Study ID Numbers: | 08-080 |
| Study First Received: | April 23, 2009 |
| Last Updated: | April 28, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by State University of New York - Downstate Medical Center:
|
kidney transplantation kidney transplant recipients |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency Cholecalciferol Vitamin D Ergocalciferols |
Vitamins 1 alpha-hydroxyergocalciferol Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 16, 2013