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Selection of Immunosuppression in Kidney Transplant Recipients Depending on Pre-transplant Donor-specific T-cell Reactivity. | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Selection of Immunosuppression in Kidney Transplant Recipients Depending on Pre-transplant Donor-specific T-cell Reactivity.

Pilot Study of Selection of Either Calcineurin Inhibitor(CNI)-Based or CNI-free Immunosuppressive Regimen Depending on the Result of Pre-transplantation Donor-specific T-cell Reactivity Measured by Enzyme-linked Immunosorbent Spot(ELISPOT) in Standard-risk Kidney Recipients.

NCT01195194•Josep M Grinyo

View on ClinicalTrials.gov

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 inhibitor(CNI)-free Sirolimus(SRL)-based immunosuppression.

Detailed Description

Non randomized, pilot, prospective, open-label trial.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age of donor and recipient between 18 and 65 years.
•2. 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.
•3. Panel reactive antibody (PRA) ≤ 20%, with negative standard cross-match.
•4. Women of childbearing potential must have a negative serum pregnancy test before randomization.
•5. 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.
•6. Signed and dated informed consent prior to transplantation.

Exclusion Criteria

•1. Multiple organ transplants
•2. Recipients of adult or pediatric en bloc kidney transplants or dual transplantation or non-heart beating donors.
•3. Evidence of active systemic or localized major infection.
•4. Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during the screening/baseline evaluation.
•5. Use of any investigational drug or treatment up to 4 weeks prior to transplantation.
•6. 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.
•7. 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.
•8. Subjects with a screening/baseline total white blood cell count \< 2,000/mm3 or absolute neutrophil count (ANC) \< 500, platelet count \< 100,000/mm3.
•9. 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.
•10. History of malignancy within 2 years of enrollment (except for adequately treated basal cell or squamous cell carcinoma of the skin).
+7 more criteria

Locations (2)

Nephrology Department. Hospital Vall d'Hebró

Barcelona, Barcelona, Spain

Nephrology Department. Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelone, Spain

Key Dates

Start Date

March 1, 2008

Primary Completion Date

June 1, 2012

Completion Date

June 1, 2013

Last Updated

February 25, 2014

Enrollment

ACTUAL participants

Conditions

Disorder Related to Renal Transplantation

Interventions

PRE-TRANSPLANT (PRE=before)

DRUG

Converting Elderly Kidney Transplant Recipients From Tacrolimus to Envarsus to Limit Neurological AE and Improve QOL

NCT03263052

View study

UNKNOWN

Bone and Cardiovascular Disease After Kidney Transplant

NCT02751099

Chronic Renal InsufficiencyDisorder Related to Renal Transplantation+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Selection of Immunosuppression in Kidney Transplant Recipients Depending on Pre-transplant Donor-specific T-cell Reactivity.

Inclusion Criteria

Exclusion Criteria

Converting Elderly Kidney Transplant Recipients From Tacrolimus to Envarsus to Limit Neurological AE and Improve QOL

Bone and Cardiovascular Disease After Kidney Transplant

Testing Immunosuppression Threshold in Renal Allografts To Extend eGFR

Contribution of Renal Function to Endothelial Dysfunction in Living Kidney Donors and Transplant Recipients

Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients