Status:
COMPLETED
Kidney Transplantation in Patients With Cystinosis
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Cystinosis
Eligibility:
All Genders
7+ years
Brief Summary
This study will test the effectiveness of a combination of anti-rejection medicines in preventing complications typically seen in cystinosis patients undergoing kidney transplants. Cystinosis is a rar...
Detailed Description
Cystinosis is an autosomal recessive disorder due to impaired cystine transport across the lysosomal membrane, resulting in abnormal cystine accumulation throughout the body. Fanconi syndrome manifest...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Candidates for a kidney transplant at the National Institutes of Health Clinical Center.
- Ability and willingness to provide informed consent (adults greater than or equal to 18.0 years) or assent (children greater than or equal to 7 years and less than 18.0 years).
- Willingness to travel to the Clinical Center for protocol samples to be collected and the ability to send samples from a local collection source and mail them overnight.
- EXCLUSION CRITERIA:
- Inability or unwillingness to comply with protocol, or to provide informed consent. Criteria include a history of noncompliance, circumstances where compliance with protocol requirements is not feasible due to living conditions, travel restrictions, lack of access to urgent medical services, or access to anti-rejection drugs once the study is completed.
- Any active malignancy or history of a hematogenous malignancy or lymphoma. Patients with primary, cutaneous basal cell or squamous cell cancers may be enrolled providing the lesions are appropriately treated prior to transplantation.
- Significant coagulopathy or requirement for anticoagulation therapy that would contraindicate allograft biopsy.
- Any known immunodeficiency syndrome.
- Peak panel reactive antibody greater than 20% or historically positive crossmatch due to HLA-specific antibodies.
- Prior kidney graft survival less than 3 years or positive T or B cell crossmatch in patients receiving repeat kidney allograft.
- Historical or current positive T cell cross match between donor and recipient.
- Pregnancy or unwillingness to practice an approved method of birth control. Acceptable methods of birth control may include barrier methods, oral contraceptives, Norplant, Depo-Provera, or partner sterility.
Exclusion
Key Trial Info
Start Date :
December 10 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 11 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00074516
Start Date
December 10 2003
End Date
June 11 2014
Last Update
October 6 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892