One-year Exploratory Study to Evaluate the Safety of Partial Replacement of CNI With Chronic Administration of Simulect in de Novo Normal-risk Kidney Transplant Recipients Treated With MPA
18 Years
75 Years
Both
Reduction in Sequelae Related to Calcineurin Inhibitors, Chimeric Antibody Sensitization, Allograft Rejection
Trial Information
One-year Exploratory Study to Evaluate the Safety of Partial Replacement of CNI With Chronic Administration of Simulect in de Novo Normal-risk Kidney Transplant Recipients Treated With MPA
The use of CNI's after kidney transplantation is associated with typical adverse effects
such as potential contribution to progressive impairment of renal function, hypertension,
and metabolic abnormalities. The study consists of a run-in phase (1 month),and treatment
phase (11 months) and safety assessment phase (1 month).
Inclusion Criteria:
- Male or female 18-75
- First kidney transplant from a living or deceased donor
- Receiving CNI and MPA
- Able to tolerate full dose MPA
- Calculated glomerular filtration rate >=30ml/min by Cockcroft-Gault equation
- Able to tolerate renal graft biopsies
- Provided written, informed consent
- Females of childbearing potential must have a negative pregnancy test within 48 hours
prior to the first Simulect administration
Exclusion Criteria:
- Known hypersensitivity to Simulect
- Current preformed PRA>10%
- Multi organ or second kidney transplant
- Use of any investigational immunosuppressive drug within 1 month of inclusion
- Female patients who are pregnant, lactating or of child bearing potential and not
practicing two approved methods of birth control
- Known malignancy or history of malignancy other than excised basal or squamous cell
carcinoma of the skin
- HBV, HCV, or HIV positive patients
- Current severe infection
- Receiving an organ from an extended criteria donor per United Network for Organ
Sharing (UNOS) guidelines
- Dialysis dependent one month post transplant
- Live too far away from the transplant center for adequate follow up
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the risk of sensitization against the chimeric antibody, Simulect.
Outcome Time Frame:
one year
Safety Issue:
Yes
Principal Investigator
Mysore Anil S. Kumar, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Drexel University College of Medicine
Authority:
United States: Institutional Review Board
Study ID:
17718
NCT ID:
NCT00928811
Start Date:
May 2009
Completion Date:
May 2011
Related Keywords:
- Reduction in Sequelae Related to Calcineurin Inhibitors
- Chimeric Antibody Sensitization
- Allograft Rejection
- Simulect
- de novo kidney transplant subjects
- calcineurin inhibitors
- Prograf
Name | Location |
|---|---|
| Drexel University College of Medicine | Philadelphia, Pennsylvania 19129 |
