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Oral Paricalcitol in Kidney Transplant Recipients
This study has been completed.

First Received on December 21, 2007.   Last Updated on November 17, 2011   History of Changes
Sponsor: Mayo Clinic
Collaborator: Abbott
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587158
  Purpose

This study is being done to find out whether patients who receive a kidney transplant can benefit from taking the medication paricalcitol (trade name Zemplar®) compared to kidney transplant recipients not taking this medication. The main possible benefits that are being studied are:

  • Lower risk for overactive parathyroid glands after kidney transplantation.
  • Lower risk of low bone density in the spine and hip after kidney transplantation. By dividing patients in the study into a group receiving Zemplar® and a group not receiving Zemplar®, it will be possible to understand the good and bad effects of Zemplar® during the first year after a kidney transplant.

Condition Intervention
Kidney Transplant
 Drug: Paricalcitol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Paricalcitol in Kidney Transplant Recipients Receiving a Corticosteroid-free Immunosuppressive Regimen

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation
Drug Information available for: 19-Nor-1alpha,25-dihydroxyvitamin D2
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To establish the efficacy of oral paricalcitol in suppressing secondary hyperparathyroidism during the first year after deceased donor or living donor Kidney transplant [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare cohorts of paricalcitol-treated and non-paricalcitol-treated kidney transplant recipients in whom additional potential long-term benefits of vitamin D analog therapy can be determined in the context of corticosteroid-free immunosuppression [ Time Frame: longer than 1 year ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: February 2006
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Group 1 (Standard Treatment Group): Patients in this group will receive Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
No Intervention: 2
Group 1 with the addition of the study medicine Zemplar® starting on day-3 of the transplant. The medicines to be taken in group 2 include Zemplar®, Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®)
 Drug: Paricalcitol
Zemplar® - this medicine, which is the medicine being studied, will be given as a capsule containing 1 microgram of Zemplar® once daily beginning the day after the transplant. It will be continued at the same dose for the first two weeks then, depending on the results of blood and urine testing, will be increased to 2 micrograms daily. The dose will remain at 2 micrograms daily until the end of the study unless there is a medical reason to reduce or stop it or unless the study is stopped early.
Other Name: Brand name is Zemplar®

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years and older.
  • First or second deceased donor or living donor renal transplant.
  • Normocalcemia or hypocalcemia.
  • Willing to give informed consent

Exclusion Criteria:

  • Third or subsequent renal transplant.
  • ABO incompatible or positive cross-match donor.
  • Multiple organ transplant recipients.
  • Diabetic with plans for future pancreas or islet transplant.
  • Evidence of donor-specific sensitization (positive T-cell and/or B-cell flow cytometric cross-match).
  • Documented hypercalcemia (total serum calcium 10.5 mg/dl on two separate occasions) prior to transplantation.
  • Serum 25(OH)vitamin D concentration ≤ 10 ng/ml
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587158

Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Abbott
Investigators
Principal Investigator: Hatem Amer, MD Mayo Clinic
  More Information

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Hatem Amer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587158     History of Changes
Other Study ID Numbers: 256-06
Study First Received: December 21, 2007
Last Updated: November 17, 2011
Health Authority: United States: Institutional Review Board;   United States: Food and Drug Administration

Additional relevant MeSH terms:
Ergocalciferols
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 12, 2012



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