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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000936
First Posted: August 31, 2001
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

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 Intervention Phase
Kidney Transplantation Drug: hOKT3 Drug: Oral Cyclosporine Drug: IV Cyclosporine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Controlled Trial of Induction Therapy in Renal Transplantation

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 292
Study Start Date: November 1999
Study Completion Date: March 2004
Arms Assigned Interventions
Experimental: Induction
subjects receiving hOKT3 induction therapy
Drug: hOKT3
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.

Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Maryland
Ilene Blechman-Krom
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SDY354
ImmPort study identifier is SDY354.
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SDY354
ImmPort study identifier is SDY354.
Study summary, -design, -demographics, -lab tests, -study files  This link exits the ClinicalTrials.gov site
Identifier: SDY354
ImmPort study identifier is SDY354.

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000936     History of Changes
Other Study ID Numbers: DAIT IN01/OLN-359
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors