Status:
COMPLETED
Selection of Immunosuppression in Kidney Transplant Recipients Depending on Pre-transplant Donor-specific T-cell Reactivity.
Lead Sponsor:
Josep M Grinyo
Collaborating Sponsors:
Carlos III Health Institute
Conditions:
Disorder Related to Renal Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The objective is to assess if low pre-transplantation donor specific T-cell reactive patients measured by Enzyme-linked immunosorbent spot (ELISPOT)assay can be safely managed with Calcineurin inhibit...
Detailed Description
Non randomized, pilot, prospective, open-label trial.
Eligibility Criteria
Inclusion
- Age of donor and recipient between 18 and 65 years.
- End-stage renal disease and scheduled to receive a primary or secondary renal allograft from a cadaveric, a living-unrelated, or a living-related donor. Patients scheduled for a second transplant must have maintained their primary graft for at least 6 months after transplantation, with the exception of graft failure due to technical reasons.
- Panel reactive antibody (PRA) ≤ 20%, with negative standard cross-match.
- Women of childbearing potential must have a negative serum pregnancy test before randomization.
- Women of childbearing potential must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.
- Signed and dated informed consent prior to transplantation.
Exclusion
- Multiple organ transplants
- Recipients of adult or pediatric en bloc kidney transplants or dual transplantation or non-heart beating donors.
- Evidence of active systemic or localized major infection.
- Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during the screening/baseline evaluation.
- Use of any investigational drug or treatment up to 4 weeks prior to transplantation.
- Treatment with voriconazole, ketoconazole, itraconazole, fluconazole, clotrimazole, astemizole, pimozide, terfenadine, erythromycin, clarithromycin, telithromycin, troleandomycin, rifampin, rifabutin, or St. John's Wort that is not discontinued prior to randomization.
- Treatment with aminoglycosides, amphotericin B, cisplatin, cisapride, metoclopramide, cimetidine, bromocriptine, danazol, or other drugs associated with renal dysfunction that are not discontinued prior to randomization.
- Subjects with a screening/baseline total white blood cell count \< 2,000/mm3 or absolute neutrophil count (ANC) \< 500, platelet count \< 100,000/mm3.
- Fasting triglycerides \> 400 mg/dL (\> 4.6 mmol/L) or fasting total cholesterol \> 300 mg/dL (\> 7.8 mmol/L) despite optimal lipid-lowering therapy.
- History of malignancy within 2 years of enrollment (except for adequately treated basal cell or squamous cell carcinoma of the skin).
- Auto-immune diseases inactive immunosuppressive treatment ( 3 months prior to inclusion).
- Patient with psychiatric disorders that could be non-compliance for the treatment.
- Non Caucasian patients.
- Active peptic ulcers that could produce intestinal absorption disorders.
- Subjects who are known to be human immunodeficiency virus(HIV) or hepatitis B virus (HBV) positive. Patients with hepatitis C virus (HCV) positive should be excluded if polymerase chain reaction (PCR) positive or transaminates values are ≥2 upper normal value (UNV).
- Diabetic patients.
- Body mass index higher than 30 Kg/m2.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01195194
Start Date
March 1 2008
End Date
June 1 2013
Last Update
February 25 2014
Active Locations (2)
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1
Nephrology Department. Hospital Vall d'Hebró
Barcelona, Barcelona, Spain, 08035
2
Nephrology Department. Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelone, Spain, 08907