Oral Paricalcitol in Kidney Transplant Recipients - Full Text View

Sponsors and Collaborators:	Mayo Clinic 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:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
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 ]

Estimated Enrollment:	100
Study Start Date:	February 2006
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Group 1 (Standard Treatment Group): Patients in this group will receive Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
2: No Intervention Group 2 except that the study medicine Zemplar® will be started on the day 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.

Arms

Assigned Interventions

1: No Intervention

Group 1 (Standard Treatment Group): Patients in this group will receive Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).

2: No Intervention

Group 2 except that the study medicine Zemplar® will be started on the day 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.

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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, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Cindy M. Groettum 507-266-8725 cgroettum@mayo.edu
Principal Investigator: Matthew D. Griffin, M.D.

Sponsors and Collaborators

Mayo Clinic

Abbott

Investigators

Principal Investigator:

Matthew D Griffin, MD

Mayo Clinic

More Information

Additional Information:

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

No publications provided

Responsible Party:	Mayo Clinic ( Matthew Griffin, M.D. )
Study ID Numbers:	256-06
Study First Received:	December 21, 2007
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00587158 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Study placed in the following topic categories:

Immunosuppressive Agents

ClinicalTrials.gov processed this record on July 02, 2009