Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients

Mariana Markell39 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Kidney Disease Kidney Transplantation

Interventions

DoxercalciferolDRUG

Active group receives doxercalciferol (Hectorol) 1mcg

placeboDRUG

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

25-OH Vitamin D3DRUG

All groups received cholecalciferol

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

SUNY Downstate Medical Center

Brooklyn, New York, United States

Outcomes

Primary Outcomes

- 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.

Time frame: 6 months

Secondary Outcomes

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)

Time frame: 6 months

Change in FGF-23 levels

The Change in FGF-23 levels (baseline as compared with 3 and 6 months) were measured.

Time frame: 6 months

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

Time frame: 6 months

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)

Time frame: 6 months

Data from ClinicalTrials.gov

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