Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00063817
• Date of registration: 07/07/2003
• Primary sponsor: National Institute of Allergy and Infectious Disease (NIAID)
• Public title: Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant
• Scientific title: Renal Allograft Tolerance Through Mixed Chimerism (ITN010ST)
• Date of first enrolment: June 2003
• Target sample size: 5
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00063817
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: A. Benedict Cosimi, MD
• Affiliation: Department of Medicine, Massachusetts General Hospital

• Name: David H. Sachs, MD
• Affiliation: Department of Medicine, Massachusetts General Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- End-stage renal disease (ESRD) without prior sensitization (defined as Panel Reactive
Antibody [PRA] greater than 0%) within the 60 days prior to transplant as measured by
cytotoxicity assays, ELISA, and flow cytometry

- Undergoing a first or second transplant

- Receiving a transplant from a living related donor who is ABO (blood type) compatible
and haploidentical (3, 4, or 5 antigen match by serologic typing)

- Cardiac ejection fraction greater than 40%

- Forced expiratory volume (FEV1) greater than 50%

- Liver function tests, bilirubin, and coagulation studies less than 2 X normal

- White blood cells greater than 2000/mm3

- Platelets greater than 100,000/mm3

Exclusion Criteria:

- Positive donor lymphocyte cross-match

- HIV-1 infected

- Positive hepatitis B surface antigen (HbsAg)

- Hepatitis C virus infected

- History of cancer

- Prior dose-limiting radiation therapy

- Pregnant, breastfeeding, or planning pregnancy within the time frame of the study

- Enrolled in another investigational drug study within 30 days prior to study entry

- Receiving maintenance immunosuppression within 3 months before the conditioning
regimen begins



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Bone Marrow Transplantation

Kidney Failure

Kidney Failure, Chronic

Kidney Transplantation

Intervention(s)

Drug: Corticosteroids

Drug: Cyclosporine A

Drug: MEDI-507

Drug: Rituximab

Procedure: Combined kidney and bone marrow transplant

Primary Outcome(s)

Ability to discontinue immunosuppressive therapy [Time Frame: 2 years]

Renal allograft acceptance [Time Frame: 2 years]

Secondary Outcome(s)

Donor-specific tolerance and chimerism [Time Frame: 2 years]

Immune reconstitution [Time Frame: 2 years]

Safety profile of the conditioning regimen [Time Frame: 2 years]

Secondary ID(s)

DAIT ITN010ST

DAIT NKD03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Immune Tolerance Network (ITN)