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Clonal Deletion on Living-Relative Donor Kidney Transplantation

NCT01408797 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2011-08-22

No results posted yet for this study

Summary

The objective of this trial is to determine if clonal deletion before kidney transplantation can effectively reduce the need for post transplant immunosuppression. The investigators will adapt a DAWN (Drugs (immunosuppressants) Added When Needed) treatment protocol to assess the effect of clonal deletion and closely monitor acute rejection, renal function, and graft survival. 15 patients eligible for the study as described below will be enrolled.

Conditions

  • Renal Transplantation
  • Uremia

Interventions

PROCEDURE

donor specific transfusion

before transplantation,200mL of donor whole blood will be transfused to the recipient

DRUG

MMF, Bortezomib

MMF and Bortezomib will be administered after donor specific transfusion

PROCEDURE

drugs added according to the immuno condition of the recipients

drugs (corticosteroid, MMF and/or CNI) will be added according to the recipients immuno event and donor specific antibody

Sponsors & Collaborators

  • Terasaki Foundation

    collaborator UNKNOWN

  • Fuzhou General Hospital

    lead OTHER

Principal Investigators

  • Tan Jianming, MD,PhD · Fuzhou General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • China

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 NCT01408797 on ClinicalTrials.gov