Clinical Trials Logo

Clinical Trial Summary

This study will examine the safety and effectiveness of a bone marrow transplant after kidney transplant (from either a living or deceased donor). An investigational medication and other treatments will be given prior to and after the transplant to help protect the transplanted kidney from being attacked by the body's immune system


Clinical Trial Description

Recipients of previous living donor (LD) or deceased donor (DD) kidney transplants that were maintained on conventional immunosuppression (I.S.), will receive a conditioning regimen that includes rituximab on study day -6, fludarabine 15 mg/m2/day on days -5 to -3 (3 doses), Cyclophosphamide (30 mg/kg/day) on days -5 and -4, followed by local thymic irradiation (7 Gy) on day -1 and Siplizumab (anti-CD2 mAb) on days, -2, -1, 0 and +1. Donor hematopoetic stem cells (HSCs) will be infused on study day 0. Methylprednisolone 250mg/day will be started on day 0 and tapered off by day 20 (Fig. 2). Prophylaxis will be provided for hemorrhagic cystitis, PCP, fungal infection, CMV, and perioperative infection. All patients who require any blood transfusion will receive only leukocyte-depleted and irradiated blood products for a period of at least 12 months following HSC Transplant. The recipients will undergo renal allograft biopsy at 6 months after HSCT. If the I.S. withdrawal criteria are met, I.S. will be slowly tapered off by 9-12 months ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05900401
Study type Interventional
Source Massachusetts General Hospital
Contact Tatsuo Kawai
Phone 617-726-0289
Email tkawai@mgh.harvard.edu
Status Recruiting
Phase Phase 1/Phase 2
Start date October 1, 2023
Completion date December 2030

See also
  Status Clinical Trial Phase
Completed NCT04510090 - Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus Phase 1
Completed NCT02546037 - Clotting With Different Dialyzer Membranes
Recruiting NCT02545920 - To Assess Ear Blood Flow During Dialysis
Completed NCT02134314 - C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI Phase 1/Phase 2
Recruiting NCT01912001 - Virtual Ward for Home Dialysis N/A
Completed NCT01158742 - Live Kidney Donor Study -Renal Function Study N/A
Completed NCT00986947 - Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates Phase 2
Withdrawn NCT00807274 - Renal Function in Adults With Congenital Heart Disease. N/A
Completed NCT00765661 - Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients Phase 2
Completed NCT00369382 - Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients Phase 4
Completed NCT00183248 - Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients Phase 1/Phase 2
Enrolling by invitation NCT05324878 - Honoring Individual Goals and Hopes: Implementing Advance Care Planning for Persons With Kidney Disease on Dialysis
Completed NCT05272800 - BIS-guided Fluid Management in HD Patients N/A
Completed NCT03836508 - Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis N/A
Completed NCT01756508 - Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury Phase 2
Completed NCT03723668 - Kidney Transplant Outcome and Organ Acceptance Practice Pattern: A Nationwide Analyses in the US and France
Recruiting NCT04277377 - Nanoparticle for DSA Removal
Terminated NCT00450333 - Dynepo Infrequent Dosing Study Phase 3
Terminated NCT03840343 - Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease Phase 1
Recruiting NCT04714853 - Different Dialysis Modalities and Diet on Gastrointestinal Biome and Azotaemic Toxins