Status:
COMPLETED
Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease
Lead Sponsor:
Indiana University School of Medicine
Conditions:
Renal Osteodystrophy
Eligibility:
All Genders
18-82 years
Phase:
NA
Brief Summary
The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and 4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control hyperparathyroidism in ...
Detailed Description
Patients with CKD stage 3 were randomly allocated (by blinded group allocation) to either cholecalciferol (4000 U per day for one month then 2000 IU daily thereafter) or doxercalciferol (2.5 mcg po da...
Eligibility Criteria
Inclusion
- age 18 years old or older, male or female
- able to sign informed consent
- CKD stage 3 (GFR 30-59 ml/min) or stage 4 (15-29 ml/min)
- intact Parathyroid hormone level (iPTH) \> 100 pg/ml for stage 3 or iPTH \> 150 pg/ml for stage 4
- calcidiol levels ≤ 20 ng/ml
- ability to ambulate without assistance
Exclusion
- intact PTH \> 400 pg/ml
- initial corrected Calcium \> 9.7 mg/dl
- initial serum Phosphorous \> 5.0 mg/dl
- initial standardized blood pressure of \> 160/100
- history of significant liver disease or cirrhosis
- anticipated requirement for dialysis in 6 months
- malabsorption, severe chronic diarrhea, or ileostomy
- no calcimimetic or active vitamin D therapy 30 days prior to enrollment
- use of digoxin, magnesium containing products, mineral oil, or cholestyramine
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00285467
Start Date
January 1 2006
End Date
December 1 2009
Last Update
May 2 2016
Active Locations (1)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202