Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients

NCT ID: NCT00889629

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-01-31

Brief 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.

Detailed 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.

Conditions

Chronic Kidney Disease; Kidney Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Doxercalciferol

Patients are randomized using an A B C D randomization scheme in which the patient and the primary investigator are blinded but the study staff is not. Active group receives doxercalciferol (Hectorol) 1mcgwith active titration based on intact PTH plus 25-OH Vitamin D3 (cholecalciferol) 400 IU. Safety labs and end point labs are monitored as per protocol, with the opportunity to increase the dose of doxercalciferol if target PTH value is not achieved by the predetermined midpoint.

Group Type: EXPERIMENTAL

Doxercalciferol

Intervention Type: DRUG

Active group receives doxercalciferol (Hectorol) 1mcg

25-OH Vitamin D3

Intervention Type: DRUG

All groups received cholecalciferol

Cholecalciferol

Patients are randomized using an A B C D randomization scheme in which the patient and the primary investigator are blinded but the study staff is not. Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol) plus 25-OH Vitamin D3 (cholecalciferol) 400IU. Safety labs and end point labs are monitored as per protocol, with the opportunity to increase the dose of doxercalciferol placebo if target PTH value is not achieved by the predetermined midpoint.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol)

25-OH Vitamin D3

Intervention Type: DRUG

All groups received cholecalciferol

Interventions

Doxercalciferol

Active group receives doxercalciferol (Hectorol) 1mcg

Intervention Type: DRUG

placebo

Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol)

Intervention Type: DRUG

25-OH Vitamin D3

All groups received cholecalciferol

Intervention Type: DRUG

Other Intervention Names

Hectorol (the other name for Doxercalciferol); Placebo for doxercalciferol; (cholecalciferol)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Mariana Markell

OTHER

Sponsor Role: lead

Responsible Party

Mariana Markell

Prinicipal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mariana Markell, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Downstate Medical Center

Locations

SUNY Downstate Medical Center

Brooklyn, New York, United States

Countries

United States

Other Identifiers

08-080

Identifier Type: -

Identifier Source: org_study_id