CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
Infusion of Donor Hematopoietic Stem Cells and Campath-1Hbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00619528
NCT00619528N/ACompleted
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HLA-Identical Sibling Renal Transplant Tolerance With Donor Hematopoietic Stem Cells and Campath-1H

Northwestern University·interventional·Posted Feb 21, 2008·Updated Feb 27, 2026

In Brief

A clinical study evaluating Infusion of Donor Hematopoietic Stem Cells and Campath-1H for Immunosuppression and 2 related conditions. Completed, enrolled 88 participants across 1 site.

Detailed Summary

The purpose of this study is to attempt to eliminate the necessity of immunosuppressive therapy for HLA-identical sibling Kidney Transplants, examine cellular chimerism of donor hematopoietic stem cell (DHSC) lineages for pairs to demonstrate immunologic unresponsiveness, and to investigate the safety and efficacy of the treatment regimen including withdrawal of immunosuppression after one year post-transplant for those recipients having received DHSC infusions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmunosuppression, Kidney Transplantation, Graft Rejection
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 21, 2008
Enrollment StartJan 1, 2008
Primary CompletionJul 1, 2022
Study CompletionSep 1, 2023
TodayJul 2, 2026
Enrollment to primary: 14.5 yearsPosted 18.4 years ago

Interventions

Infusion of Donor Hematopoietic Stem Cells and Campath-1Hbiological

Intervention: a four-dose (peri-operative and 3, 6, and 9-month boost) DHSC infusion protocol using two-dose Campath-1H induction combined with transient (conditioning) Tacrolimus/Sirolimus and MMF therapy will result in a high degree of macro-chimerism (\>10%), and a robust prolonged donor-specific (post-thymic) immunoregulatory condition that will allow renal transplant survival in the absence of permanent immunosuppression.