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Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00889629
Recruitment Status : Unknown
Verified April 2009 by State University of New York - Downstate Medical Center.
Recruitment status was:  Recruiting
First Posted : April 29, 2009
Last Update Posted : April 29, 2009
Sponsor:
Information provided by:
State University of New York - Downstate Medical Center

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Kidney Transplantation Drug: Doxercalciferol Drug: placebo Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2008
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Hectorol plus 25-OH Vitamin D3
Drug: Doxercalciferol
1 mcg qd then uptitrated as specified in protocol
Other Name: Hectorol

Placebo Comparator: 2
placebo plus 25-OH Vitamin D3
Drug: placebo
placebo of doxercalciferol




Primary Outcome Measures :
  1. Number of patients achieving the target iPTH value of 100 pg/ml or lower [ Time Frame: 6 months ]
  2. Change in 1,25 D2 and D3, 25-OH Vitamin D3 levels [ Time Frame: 6 months ]
  3. iPTH at baseline, 1, 3 and 6 months (absolute value and percent change from baseline) [ Time Frame: 6 months ]
  4. Change in FGF-23 levels at baseline, 1, 3 and 6 months [ Time Frame: 6 months ]
  5. Change in serum bone turnover markers [ Time Frame: 6 months ]
  6. Change in Protein/creatinine ratio and/or 24 hour urine for protein at baseline, 1, 3 and 6 months [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00889629


Locations
United States, New York
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11234
Contact: Sima Terebelo, MPH, RPA-C    718-270-8216      
Principal Investigator: Mariana Markell, MD         
Sub-Investigator: Sima Terebelo, MPH, RPA-C         
Sponsors and Collaborators
State University of New York - Downstate Medical Center
Investigators
Principal Investigator: Mariana Markell, MD State University of New York - Downstate Medical Center

Responsible Party: Dr Mariana Markell, SUNY Downstate Medical Center
ClinicalTrials.gov Identifier: NCT00889629     History of Changes
Other Study ID Numbers: 08-080
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: April 29, 2009
Last Verified: April 2009

Keywords provided by State University of New York - Downstate Medical Center:
kidney transplantation
kidney transplant recipients

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
1 alpha-hydroxyergocalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents