Status:
TERMINATED
Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney Transplant Patients
Lead Sponsor:
Emory University
Conditions:
Hyperparathyroidism, Secondary
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patients with kidney failure on dialysis can be successfully transplanted. However, many of them do not attain a normal kidney function and/or present a slow deterioration of kidney function after tra...
Detailed Description
The investigators plan to study the cardiovascular and bone effects of Hectorol® in 100 kidney transplant recipients. The kidney transplant patients will be screened for kidney transplant dysfunction ...
Eligibility Criteria
Inclusion
- Kidney transplant recipient \> 18 year/old with reduced and stable kidney function (estimated GFR 25-60 ml/min/1.73m2)
- iPTH levels between 120 and 500 pg/ml
- Stable immunosuppressive therapy (5-10 mg Prednisone/day, stable dosage of calcineurin inhibitors, or other immunosuppressive agents for at least 6 months)
Exclusion
- Recent rejection episode (\< 3 months)
- One of the following: baseline estimated GFR\>60 ml/min/1.73m2 or \<25 ml/min/1.73m2, albumin-corrected Ca\>9.5 mg/dl or serum phosphorus \>4.6 mg/dl.
- Recipients of dual transplant organs with exception of kidney-pancreas
- Patients already receiving treatment with Vitamin D analogues
- Severe peripheral vascular disease or coronary artery disease
- History of previous parathyroidectomy
- Current alcohol or drug abuse
- Pregnant or nursing woman or female of child-bearing age not receiving contraception
- Other comorbidities that in the opinion of the investigators would reduce expected patient's survival and preclude study completion
- Medications that could interfere with Hectorol® metabolism
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00646282
Start Date
April 1 2008
End Date
January 1 2010
Last Update
January 26 2015
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30322