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

NCT01195194 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2014-02-25

No results posted yet for this study

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.

Conditions

  • Disorder Related to Renal Transplantation

Interventions

DRUG

PRE-TRANSPLANT (PRE=before)

All patients will start with Thymoglobulin 1 mg/kg before transplant followed by 0,5 mg/kg/d during the next 5 days (total accumulated 3,5 mg/kg). Steroids will be administered at 0,25 mg/kg/d until month 3rd, followed by 0,1 mg/kg/d thereafter. Mycophenolate Mofetil: Pre-transplant 2 grams iv. After transplantation 1g/12 hours, starting iv and changing to oral formulation as soon as patient starts with oral intake (targeting mycophenolic acid (MPA) C0h levels 2-5 µg/mL).

Sponsors & Collaborators

  • Carlos III Health Institute

    collaborator OTHER_GOV

  • Josep M Grinyo

    lead OTHER

Principal Investigators

  • Josep M Grinyó, PhD MD · Nephrology Department. Hospital de Bellvitge. Spain

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2012-06-30
Completion
2013-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01195194 on ClinicalTrials.gov