A Study To Test An Anti-Rejection Therapy After Kidney Transplantation
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|ClinicalTrials.gov Identifier: NCT00000936|
Recruitment Status : Terminated
First Posted : August 31, 2001
Last Update Posted : January 11, 2017
Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Two medications in this study are currently used in children, but there is no information regarding which drug is safer or more effective.
Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for an improved post-transplant treatment, such as the induction therapy used in this study.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation||Drug: hOKT3 Drug: Oral Cyclosporine Drug: IV Cyclosporine||Phase 3|
Renal transplantation is recognized as the treatment of choice for children with chronic renal failure. However, patient and graft survival rates in young children are unacceptably low. In preliminary studies, OKT3 (a monoclonal antibody) induction therapy received post transplant has been more successful than standard immunosuppression alone in improving graft survival. This study is designed to assess the impact of induction therapy on graft survival in pediatric kidney transplant patients.
Patients are assigned to OKT3 induction or no induction in a 1:1 ratio. Randomization to oral cyclosporine of either Sandimmune or Neoral is also done in a 1:1 ratio. Group 1 receives OKT3 intraoperatively followed by Neoral. Group 2 receives OKT3 intraoperatively followed by Sandimmune. OKT3 is administered at 2.5 mg (if weight less than 30 kg) or 5 mg (if weight above 30 kg) per day for a maximum of 14 days. Group 3 receives IV cyclosporine followed by Neoral. Group 4 receives IV cyclosporine followed by Sandimmune. Oral cyclosporine is administered in a masked preparation. The dose for Sandimmune and Neoral is the same; patients 6 years of age and older begin at a dose of 15 mg/kg/day and patients under 6 years of age receive 500 mg/m2/day. Patients will receive concomitant medications including steroids (IV and po), Nifedipine, anti-CMV therapy, Bactrim, Azathioprine or Mycophenolate Mofetil. Kidney function, incidence of viral infection, graft survival, and incidence of malignancy will be measured to assess the role of OKT3 induction and the role of rejection in graft failure. Graft function will be evaluated at 1-, 2-, and 4-year intervals.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||292 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Controlled Trial of Induction Therapy in Renal Transplantation|
|Study Start Date :||November 1999|
|Actual Study Completion Date :||March 2004|
subjects receiving hOKT3 induction therapy
Administered both during and after transplantation in IV form. Dosage determined by individual weight and given for a maximum of 14 days.Drug: Oral Cyclosporine
Administered orally as either sandimmune or neoral at a dose determined by weight. Patients 6 years of age and older begin at a dose of 15 mg/kg/day and patients under 6 years of age receive 500 mg/m2/day, for the duration of the study.
Active Comparator: Induction Free Therapy
Patients not receiving induction therapy
Drug: Oral Cyclosporine
Administered orally as either sandimmune or neoral at a dose determined by weight. Patients 6 years of age and older begin at a dose of 15 mg/kg/day and patients under 6 years of age receive 500 mg/m2/day, for the duration of the study.Drug: IV Cyclosporine
Administered intravenously (IV) both during and after transplantation at a dosage determined by individual age.
- To determine one-year graft function, as measured by graft survival and serum creatinine of children undergoing OKT3 induction versus no induction [ Time Frame: At 1 year ]
- To compare the efficacy of Sandimmune and Neoral with respect to graft function [ Time Frame: Throughout study ]
- Two and four-year graft functions [ Time Frame: At 2 and 4 years ]
- Safety with respect to viral infections and malignancies in children undergoing a renal transplant [ Time Frame: Throughout study ]
- Frequency and severity of rejection episodes [ Time Frame: Throughout study ]
- Time to first rejection [ Time Frame: Throughout study ]
- Length and frequency of hospitalization [ Time Frame: Throughout study ]
- Nature of acute cellular rejection at a molecular level [ Time Frame: Throughout study ]
- Nature of "heightened immune response" of younger children by studying gene expression in surveillance biopsies [ Time Frame: Throughout study ]
- Correlate intragraft events during rejection with cytokine profile in the peripheral blood [ Time Frame: Throughout study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000936
|United States, Maryland|
|Rockville, Maryland, United States, 20850|