Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease

Not Applicable

Completed

• Conditions: Renal Osteodystrophy
• Interventions: Drug: doxercalciferol; Drug: Cholecalciferol

• Registration Number: NCT00285467
• Lead Sponsor: Indiana University School of Medicine

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 this group is unknown. The National Kidney Foundation presented guidelines in 2003 recommending vitamin D supplementation for vitamin D insufficient patients and active vitamin D therapy in patients with sufficient levels. These guidelines are based on opinion since there are no significant trials to determine if vitamin D supplementation is effective in this population. The active vitamin D metabolites doxercalciferol, paricalcitol, and calcitriol have been shown to effectively suppress parathyroid hormone (PTH), but have not been compared with vitamin D supplementation with a calciferol (ergocalciferol or cholecalciferol). Beyond hyperparathyroidism, small studies suggest vitamin D replacement in vitamin D insufficient non-CKD subjects result in improved pain, feeling of well being, blood pressure and strength. In this proposed study we wish to directly compare the effectiveness of cholecalciferol versus doxercalciferol in suppressing elevated PTH levels in subjects with CKD not on dialysis who have vitamin D insufficiency in a three month study. Secondary endpoints will be change in blood pressure.

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 daily. Assessments for blood endpoints (primary end point PTH; secondary calcium, phosphorus) were done monthly. Other assessments (blood pressure) were done at baseline and at 3 months.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-31
• Study First Submitted QC: 2006-01-31
• Study First Posted: 2006-02-02
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2012-03-27
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-18
• Last Update Submitted: 2016-04-18
• Results First Posted: 2016-05-02
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doxercalciferol	doxercalciferol	doxercalciferol 1 mcg capsule orally daily for 3 months. This is a form of vitamin D that does not require activation by enzymes in the liver and kidney.
Cholecalciferol	Cholecalciferol	cholecalciferol 4000 IU capsule orally daily for one month, then 2000 IU capsule daily orally for 2 months. this form of vitamin D requires activation by cells of the body.

Primary Outcome Measures

Name	Time	Method
Percent Reduction in PTH	3 month	Percent reduction in PTH from baseline to 3 months

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure at 3 Months	3 month	systolic blood pressure at 3 months

Trial Locations

Locations (1)

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States