Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889629
• Other study ID #: 08-080
• Status: Completed
• Phase: Phase 4
• Start date: November 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2019
• Source: State University of New York - Downstate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Kidney Transplantation
• Renal Insufficiency, Chronic

Intervention

Drug:
• Doxercalciferol
Active group receives doxercalciferol (Hectorol) 1mcg
• placebo
Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol)
• 25-OH Vitamin D3
All groups received cholecalciferol

Locations

Country	Name	City	State
United States	SUNY Downstate Medical Center	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
Mariana Markell	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- iPTH value of 100 pg/ml or lower	The number of patients achieving the target iPTH value of 100 pg/ml or lower measured. Change in the level of iPTH (baseline as compared with 3 and 6 months) using both absolute value and percent change from baseline.	6 months
Secondary	Change in 1,25 D2 and D3, 25-OH Vitamin D3 levels	The Change in the levels of 1,25 D2 and D3, 25-OH Vitamin D3 levels (baseline as compared with 3 month and end of study)	6 months
Secondary	Change in FGF-23 levels	The Change in FGF-23 levels (baseline as compared with 3 and 6 months) were measured.	6 months
Secondary	Change in serum bone turnover markers	The Change in the levels of serum osteocalcin, bone alkaline phosphatase and n-telopeptide of Type I collagen levels (baseline versus 3 and 6 months	6 months
Secondary	Change in Protein/creatinine ratio	Change in the level of Protein/creatinine ratio and or 24 hour urine for protein (baseline as compared with 3 and 6 months); 6. Change in the level of Protein/creatinine ratio (baseline as compared with 3 and 6 months); The Change in the level of Protein/creatinine ratio (baseline as compared with 3 and 6 months)	6 months