A Study To Test An Anti-Rejection Therapy After Kidney Transplantation

Kidney Transplantation Clinical Trial

Official title:

Controlled Trial of Induction Therapy in Renal Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00000936
• Other study ID #: DAIT IN01/OLN-359
• Status: Terminated
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: January 10, 2017
• Start date: November 1999
• Est. completion date: March 2004

Study information

• Verified date: January 2017
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 292
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

Inclusion Criteria

Children and young adults may be eligible for this study if they:

• Are not yet 21 years of age.

• Are receiving their first or second transplant.

• Are not pregnant.

• Agree to practice sexual abstinence or agree to use an effective

• method of birth control/contraception during the study and

• for 1 year after.

Exclusion Criteria

Children and young adults will not be eligible for this study if they:

• Are recipients of multiple organs other than kidneys.

• Are recipients of three or more transplants.

• Are HIV positive.

• Are Hepatitis B surface antigen positive.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• hOKT3
Administered both during and after transplantation in IV form. Dosage determined by individual weight and given for a maximum of 14 days.
• 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.
• IV Cyclosporine
Administered intravenously (IV) both during and after transplantation at a dosage determined by individual age.

Locations

Country	Name	City	State
United States	Ilene Blechman-Krom	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine one-year graft function, as measured by graft survival and serum creatinine of children undergoing OKT3 induction versus no induction		At 1 year	No
Primary	To compare the efficacy of Sandimmune and Neoral with respect to graft function		Throughout study	No
Secondary	Two and four-year graft functions		At 2 and 4 years	No
Secondary	Safety with respect to viral infections and malignancies in children undergoing a renal transplant		Throughout study	Yes
Secondary	Frequency and severity of rejection episodes		Throughout study	Yes
Secondary	Time to first rejection		Throughout study	No
Secondary	Length and frequency of hospitalization		Throughout study	No
Secondary	Nature of acute cellular rejection at a molecular level		Throughout study	No
Secondary	Nature of "heightened immune response" of younger children by studying gene expression in surveillance biopsies		Throughout study	No
Secondary	Correlate intragraft events during rejection with cytokine profile in the peripheral blood		Throughout study	No

External Links

•   Division of Allergy, Immunology, and Transplantation (DAIT)
•   The National Institute of Allergy and Infectious Diseases (NIAID)