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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 21, 2007 | ||||
| Last Updated Date | September 9, 2009 | ||||
| Start Date ICMJE | February 2006 | ||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00587158 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Oral Paricalcitol in Kidney Transplant Recipients | ||||
| Official Title ICMJE | Oral Paricalcitol in Kidney Transplant Recipients Receiving a Corticosteroid-free Immunosuppressive Regimen | ||||
| Brief Summary | 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:
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| Detailed Description | In order to take part in the study you will already have been accepted for kidney transplantation from a living donor or from a deceased donor at Mayo Clinic Rochester. After you have agreed to take part in the study you will be put in one of two groups by chance (as in the flip of a coin): Group 1 (Standard Treatment Group): Patients in this group will receive a combination of four anti-rejection medications that have been used at Mayo Clinic Rochester for many kidney transplant patients and does not include any research study medicines. These medications will include:
(a) 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. (b) Alemtuzumab (Campath®) - this medicine will be given intravenously on the day of the transplant during surgery. (c) Methylprednisolone (Solumedrol®) - this medicine, which is part of a family of medicines often referred to as corticosteroids, will be given intravenously on the day of the transplant during surgery. This will be the only planned dose of corticosteroid medicine you will receive although this medicine and a tablet form called Prednisone may be given at a later time if you have an episode of transplant rejection. (d) Mycophenolate Mofetil (Cellcept®) - this medicine will be given by mouth twice daily beginning the evening before the transplant (for living donor transplants) or the day of the transplant (for deceased donor transplants). It will be continued for as long as you have your transplant unless there is a medical reason to stop it. (e) Tacrolimus (Prograf®) - this medicine will be given by mouth once daily beginning on the fourth day after the transplant. It will continue for as long as you have your transplant unless there is a medical reason to stop it. The dose will be adjusted based on a blood test that will be done between twice a week and once a month for as long as you take the medicine. Both groups of patients will be treated by the same team of doctors, nurses and nurse coordinators that care for all kidney transplant patients at Mayo Clinic Rochester. The procedures and treatments for your transplant will be the same as those recommended at Mayo Clinic Rochester for all patients receiving a kidney transplant. These include the surgical operation to carry out the transplant; the need to take anti-rejection medicines by mouth for the rest of your life; the need to have blood and urine testing at regular intervals for the rest of your life to monitor the progress of your transplant; and the recommendation to have a biopsy of your transplant carried out on three occasion during the first two years after the transplant surgery. These procedures and their potential complications will be described to you in detail by your transplant physician, transplant surgeon, and transplant coordinator. The study will not require extra hospital or outpatient visits compared to the usual care for all kidney transplant patients at Mayo Clinic Rochester. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Kidney Transplant | ||||
| Intervention ICMJE | Drug: Paricalcitol | ||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | February 2010 | ||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00587158 | ||||
| Responsible Party | Matthew Griffin, M.D., Mayo Clinic | ||||
| Study ID Numbers ICMJE | 256-06 | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | Abbott | ||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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