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Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients

NCT00889629 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2019-02-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Doxercalciferol

Active group receives doxercalciferol (Hectorol) 1mcg

DRUG

placebo

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

DRUG

25-OH Vitamin D3

All groups received cholecalciferol

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • Mariana Markell

    lead OTHER

Principal Investigators

  • Mariana Markell, MD · State University of New York - Downstate Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00889629 on ClinicalTrials.gov