CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Alemtuzumab +5 moredrug
Likely dose
Alemtuzumab 2 doses IV on Days 0 and 4; Tacrolimus daily starting Day 1; Mycophenolate mofetil oral daily starting Day 0; Sirolimus oral daily starting Months 4-6; Donor bone marrow stem cells 2 doses IV (Day 5 and Months 4-6)AI-extracted
Key inclusion· 5
  • ✓Weight greater than 40 kg
  • ✓Living-related, 1-haplotype-matched primary kidney allograft
  • ✓Negative B-cell and T-cell cytotoxic and flow cytometry crossmatch with PRA <10%
  • ✓Normal echocardiogram with ejection fraction >50%
Key exclusion· 14
  • ✕Prior organ transplant other than kidney
  • ✕ABO-incompatible donor kidney
  • ✕HIV infection
  • ✕Hepatitis C antibody positive

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

Search/NCT00183248
NCT00183248Phase 2Completed
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Pilot Study Using Donor Stem Cells and Campath-1H to Induce Renal Transplant Tolerance (ITN022ST)

University of Miami·interventional·Posted Sep 16, 2005·Updated Oct 2, 2012

In Brief

A Phase 2 clinical trial evaluating Alemtuzumab, Mycophenolate mofetil, and 4 other interventions for Kidney Transplantation and 2 related conditions. Completed, enrolled 9 participants across 1 site.

Detailed Summary

Alemtuzumab is a man-made antibody used to treat certain blood disorders. This study will evaluate treatment of kidney transplant recipients with alemtuzumab and other immune system suppressing medications with or without infusions of bone marrow stem cells from the kidney donor. The purpose of this study is to find out which strategy is more effective in preventing organ rejection and maintaining patient health.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation, Kidney Disease, Kidney Failure
CountriesUnited States
CollaboratorsImmune Tolerance Network (ITN)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartSep 1, 2004
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 20.8 years ago

Interventions

Alemtuzumabdrug

Immunosuppressant; 2 doses of drug by intravenous (IV) infusion on Days 0 and 4

Mycophenolate mofetildrug

Immunosuppressant; oral daily dose starting Day 0 until withdrawal or end of the study

Sirolimusdrug

Immunosuppressant; oral daily dose starting between Months 4 and 6 post-transplant until withdrawal or end of the study

Tacrolimusdrug

Immunosuppressant; daily dose starting Day 1 until withdrawal or end of the study

Donor bone marrow stem cell infusionprocedure

2 doses of kidney donor's bone marrow stem cells by IV infusion on Day 5 and sometime between Months 4 and 6

Kidney transplantprocedure

Occurs at study entry