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Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00889629
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Mariana Markell, 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 Drug: 25-OH Vitamin D3 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 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
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Doxercalciferol
Active group receives doxercalciferol (Hectorol) 1mcg
Other Name: Hectorol (the other name for Doxercalciferol)

Drug: 25-OH Vitamin D3
All groups received cholecalciferol
Other Name: (cholecalciferol)

Placebo Comparator: 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.
Drug: placebo
Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol)
Other Name: Placebo for doxercalciferol

Drug: 25-OH Vitamin D3
All groups received cholecalciferol
Other Name: (cholecalciferol)




Primary Outcome Measures :
  1. - iPTH value of 100 pg/ml or lower [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Change in 1,25 D2 and D3, 25-OH Vitamin D3 levels [ Time Frame: 6 months ]
    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)

  2. Change in FGF-23 levels [ Time Frame: 6 months ]
    The Change in FGF-23 levels (baseline as compared with 3 and 6 months) were measured.

  3. Change in serum bone turnover markers [ Time Frame: 6 months ]
    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

  4. Change in Protein/creatinine ratio [ Time Frame: 6 months ]

    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)




Information from the National Library of Medicine

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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
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United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11234
Sponsors and Collaborators
Mariana Markell
Genzyme, a Sanofi Company
Investigators
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Principal Investigator: Mariana Markell, MD State University of New York - Downstate Medical Center

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Responsible Party: Mariana Markell, Prinicipal Investigator, State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier: NCT00889629    
Other Study ID Numbers: 08-080
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mariana Markell, State University of New York - Downstate Medical Center:
kidney transplantation
kidney transplant recipients
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Vitamin D
Ergocalciferols
Cholecalciferol
1 alpha-hydroxyergocalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents