Pediatric Kidney Transplant Without Calcineurin Inhibitors
NCT ID: NCT00023231
Last Updated: 2016-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2001-02-28
2006-08-31
Brief Summary
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Kidney transplantation can help children with end-stage kidney disease. However, it has been difficult to find treatment for donor graft rejection that does not have a lot of side effects. Researchers hope to find treatments (immunosuppressants) with fewer side effects. One approach is to avoid using calcineurin inhibitors and to try a new drug known as sirolimus instead. Another is to use steroids less often. This study will test whether using sirolimus, fewer steroid treatments, MMF, and certain antibodies will improve long-term graft survival in children receiving kidney transplants from living donors.
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Detailed Description
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Evaluations prior to transplantation include a complete history and physical examination, CBC, liver function tests, and antibodies for CMV, EBV, HIV, HbsAG, and HCV. All appropriate vaccinations are provided before transplantation. Transplant recipients receive immunosuppression therapy using antibody induction (daclizumab), corticosteroids, mycophenolate mofetil, and sirolimus. Serum sirolimus levels are measured so that doses can be adjusted to maintain certain blood levels of the drug. Bactrim and ganciclovir are given for infection prophylaxis. If the patient has consistent high levels of fasting cholesterol, treatment with lipitor may be given. A transplant biopsy is performed at the time of the transplant and at 3, 6, and 12 months post transplantation and at times when a rejection is suspected. A radionuclide GFR is done at the same time points, and at 1, 24, and 36 months. The protocol biopsies, blood, and urine samples will be analyzed by genomic methods to determine differences in gene expression post transplantation. In the event of a first acute rejection, patients are treated with Solu-Medrol for 3 consecutive days. A second rejection (at the discretion of the transplant center) or severe rejection (Banff Grade 3) is treated with antibody therapy and, after a second or severe rejection, the immunosuppressant regimen is changed. Patients are followed for 36 months with routine physical examinations and laboratory assessments.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Participants will receive immunosuppression therapy using antibody induction (daclizumab), corticosteroids, mycophenolate mofetil, and sirolimus prior to transplantation. Bactrim and ganciclovir will be taken for infection prophylaxis. If the participant has consistent high levels of fasting cholesterol, treatment with lipitor may be given.
Daclizumab
1 mg/kg/dose at study entry and Weeks 2, 4, 6, and 8
Methylprednisolone/prednisone
Dosage is dependent on weight and varies throughout study. Refer to protocol for more information.
Mycophenolate mofetil
Solution or oral tablet taken daily. Dosage depends on body surface area.
Sirolimus
Oral tablet taken once prior to transplant. Dosage dependent on body surface area.
Bactrim
Oral tablet taken three times per week. Dosage is dependent on weight.
Ganciclovir
Oral tablet taken daily. Dosage is dependent on weight.
Lipitor
Oral tablet taken daily
Interventions
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Daclizumab
1 mg/kg/dose at study entry and Weeks 2, 4, 6, and 8
Methylprednisolone/prednisone
Dosage is dependent on weight and varies throughout study. Refer to protocol for more information.
Mycophenolate mofetil
Solution or oral tablet taken daily. Dosage depends on body surface area.
Sirolimus
Oral tablet taken once prior to transplant. Dosage dependent on body surface area.
Bactrim
Oral tablet taken three times per week. Dosage is dependent on weight.
Ganciclovir
Oral tablet taken daily. Dosage is dependent on weight.
Lipitor
Oral tablet taken daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are 21 years of age and under.
* Are kidney recipients of living-donor grafts, except when living-donor grafts are identically matched.
Exclusion Criteria
* Are recipients of identical (HLA matched) living-donor grafts.
* Are recipients of cadaver-donor grafts.
* Have certain abnormal kidney diseases that may return.
* Have failed 2 or more previous kidney transplants.
* Have fat abnormalities that are inherited or present at high levels.
21 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Locations
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Lauren Schenker
Rockville, Maryland, United States
Countries
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References
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Harmon W, Meyers K, Ingelfinger J, McDonald R, McIntosh M, Ho M, Spaneas L, Palmer JA, Hawk M, Geehan C, Tinckam K, Hancock WW, Sayegh MH. Safety and efficacy of a calcineurin inhibitor avoidance regimen in pediatric renal transplantation. J Am Soc Nephrol. 2006 Jun;17(6):1735-45. doi: 10.1681/ASN.2006010049. Epub 2006 May 10.
Iacomini J, Sayegh MH. Measuring T cell alloreactivity to predict kidney transplant outcomes: are we there yet? J Am Soc Nephrol. 2006 Feb;17(2):328-30. doi: 10.1681/ASN.2005121264. Epub 2005 Dec 28. No abstract available.
Schachter AD, Meyers KE, Spaneas LD, Palmer JA, Salmanullah M, Baluarte J, Brayman KL, Harmon WE. Short sirolimus half-life in pediatric renal transplant recipients on a calcineurin inhibitor-free protocol. Pediatr Transplant. 2004 Apr;8(2):171-7. doi: 10.1046/j.1399-3046.2003.00148.x.
Hoerning A, Koss K, Datta D, Boneschansker L, Jones CN, Wong IY, Irimia D, Calzadilla K, Benitez F, Hoyer PF, Harmon WE, Briscoe DM. Subsets of human CD4(+) regulatory T cells express the peripheral homing receptor CXCR3. Eur J Immunol. 2011 Aug;41(8):2291-302. doi: 10.1002/eji.201041095. Epub 2011 Jun 24.
Related Links
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National Institute of Allergy and Infectious Diseases (NIAID)
Division of Allergy, Immunology, and Transplantation (DAIT)
Other Identifiers
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CN01
Identifier Type: -
Identifier Source: secondary_id
DAIT CN01
Identifier Type: -
Identifier Source: org_study_id
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