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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00560300
Other study ID # DK35423 (completed)
Secondary ID
Status Completed
Phase Phase 2
First received November 13, 2007
Last updated January 12, 2010
Start date November 2000
Est. completion date November 2006

Study information

Verified date January 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

To examine the effects of two types of active vitamin D (calcitriol and doxercalciferol) and two phosphate binders (sevelamer and calcium carbonate) on the bone disease and blood tests of children with kidney failure


Description:

Pediatric patients treated with CCPD who displayed biochemical and bone biopsy proven secondary hyperparathyroidism were randomly assigned to one of 2 vitamin D analogues (calcitriol or doxercalciferol) and one of two phosphate binders (sevelamer or calcium carbonate) in a two by two factorial designed prospective trial. Serum biochemical measurements were obtained at baseline and monthly throughout the 8 months of the trial. Bone biopsy was obtaine at baseline and repeated at study completion.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 21 Years
Eligibility Inclusion Criteria:

- Stable end-stage kidney disease treated with continuous cycling peritoneal dialysis,

- Biochemical evidence of secondary hyperparathyroidism (PTH>400 pg/ml) with bone biopsy evidence of high turnover bone disease

Exclusion Criteria:

- History of parathyroidectomy

- Growth hormone

- Prednisone, or other immunosuppressant medication within the past year.

- Recent history of medication non-compliance.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
1 alpha D2
Vitamin D sterol
1,25 dihydroxy vitamin D3
Active vitamin D sterol
Sevelamer HCl
Phosphate binder
Calcium Carbonate
Phosphate binder

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome

Type Measure Description Time frame Safety issue
Primary Bone Formation Rate 8 months
Secondary Bone histomorphometric parameters other than bone formation rate, biochemical parameters (phosphorus, calcium, PTH, alkaline phosphatase, FGF-23, vitamin D dose) 8 months
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