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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00023231 |
The purpose of this study is to see the effect of using drugs other than calcineurin inhibitors to improve the rate of kidney transplant failure.
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.
Condition | Intervention |
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End-Stage Renal Disease |
Drug: Daclizumab Drug: Methylprednisolone/prednisone Drug: Mycophenolate mofetil Drug: Sirolimus Drug: Bactrim Drug: Ganciclovir Drug: Lipitor |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Calcineurin Inhibitor Sparing Protocol in Living Donor Pediatric Kidney Transplantation |
Enrollment: | 35 |
Study Start Date: | February 2001 |
Estimated Study Completion Date: | February 2009 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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.
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Drug: Daclizumab
1 mg/kg/dose at study entry and Weeks 2, 4, 6, and 8
Drug: Methylprednisolone/prednisone
Dosage is dependent on weight and varies throughout study. Refer to protocol for more information.
Drug: Mycophenolate mofetil
Solution or oral tablet taken daily. Dosage depends on body surface area.
Drug: Sirolimus
Oral tablet taken once prior to transplant. Dosage dependent on body surface area.
Drug: Bactrim
Oral tablet taken three times per week. Dosage is dependent on weight.
Drug: Ganciclovir
Oral tablet taken daily. Dosage is dependent on weight.
Drug: Lipitor
Oral tablet taken daily
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Renal transplantation is widely recognized as the treatment of choice for children with end-stage renal disease (ESRD). Although outcomes of renal transplantation in children have improved during the past decade, success has been limited by both non-specific tolerance and the complications associated with immunosuppressants. Steroids and calcineurin inhibitors have the most toxic side effects. Use of sirolimus for immunosuppression has not been associated with as many complications. Recent studies from Europe have demonstrated that sirolimus can be combined with MMF and steroids to provide excellent graft survival in the absence of calcineurin inhibitors. Steroid side-effects can be lessened by tapering the steroid dose to an every-other-day schedule. This protocol tests whether immunosuppression by IL-2r antibody, sirolimus, MMF, and alternate-day steroids will provide comparable graft survival for living donor recipients, compared to current immunosuppression, but with reduced complications of calcineurin inhibitors.
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.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | DAIT CN01, CN01 |
Study First Received: | August 29, 2001 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00023231 History of Changes |
Health Authority: | United States: Federal Government |
Sirolimus Anti-Inflammatory Agents Prednisone Renal Insufficiency Immunologic Factors Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Kidney Failure, Chronic Antiemetics Trimethoprim-Sulfamethoxazole Combination Prednisolone acetate Neuroprotective Agents Hormones Urologic Diseases |
Mycophenolate mofetil Kidney Diseases Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Daclizumab Methylprednisolone acetate Ganciclovir Immunosuppressive Agents Antiviral Agents Glucocorticoids Renal Insufficiency, Chronic Prednisolone Peripheral Nervous System Agents Atorvastatin Kidney Failure |
Anti-Inflammatory Agents Anti-Infective Agents Renal Insufficiency Immunologic Factors Antineoplastic Agents Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Kidney Failure, Chronic Antiemetics Prednisolone acetate Hormones Neuroprotective Agents Urologic Diseases Therapeutic Uses |
Mycophenolate mofetil Kidney Diseases Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Daclizumab Gastrointestinal Agents Methylprednisolone acetate Ganciclovir Immunosuppressive Agents Glucocorticoids Protective Agents Antiviral Agents Pharmacologic Actions Renal Insufficiency, Chronic Autonomic Agents |