Combined Blood Stem Cell and Kidney Transplant of One Haplotype Match Living Donor Pairs.

NCT01165762 | Unknown Phase 1 DMC

• 2 other identifiers: SU-06232010-6408P01HL075462
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone marrow Transplantation are enrolling patients into a research study to determine if donor stem cells given after a living related one Haplotype match kidney transplantation will change the immune system such that immunosuppressive drugs can be completely withdrawn.

Conditions

ESRD

Outcome Measures

Primary Outcomes (1)

• Long term freedom from transplant immunosuppressive drugs, safety, rate of infection, graft survival and patient survival.

  Subjects on study will have tapering of the immunosuppressive medication and withdrawal of the immunosuppressive medication if withdrawal criteria are met.

  5 years and indefinitely if possible

Study Arms (1)

Immune Tolerance, Kidney transplantation

EXPERIMENTAL

Induction of immune tolerance in Haplotype matched living donor kidney transplantation.

Drug: Immune Tolerance

Interventions

Immune Tolerance DRUG

Immune tolerance Kidney and hematopoietic cell transplantation with a conditioning regimen of total lymphoid irradiation and antithymocyte globulin followed by immunosuppressive drugs for 18 months. Immunosuppressive drugs are stopped if stable chimerism is achieved and there is no rejection of the transplant kidney. The IDE used in this study is the column used for hematopoietic cell sorting.

Also known as: Kidney transplantation

Immune Tolerance, Kidney transplantation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All consenting adults who are 18 to 60 years, living donor transplant candidates and have a haplotype related living donor or \> 2 HLA antigen matched, unrelated, living donor (including at least one HLA-DR antigen match plus at least one antigen match of either HLA-A or HLA-B).
• Patients who agree to participate in the study and sign an Informed Consent.
• Patients who have no known contraindication to administration of rabbit ATG or radiation.
• Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 24 months post-transplant.
• ABO compatible.

You may not qualify if:

• Previous treatment with rabbit ATG or a known allergy to rabbit proteins.
• History of malignancy with the exception of non-melanoma skin malignancies.
• Pregnant women or nursing mothers.
• Serological evidence of HIV, Hepatitis B or Hepatitis C infection.
• Seronegative for Epstein-Barr virus, if donor is seropositive.
• Leukopenia (with a white blood cell count \< 3000/mm3) or thrombocytopenia (with a platelet count \< 100,000/mm3).
• Panel Reactive Antibody greater than 80% or demonstration of donor specific antibody (DSA).
• Prior organ transplantation.
• High risk of primary kidney disease recurrence (e.g atypical HUS). However, patients with primary FSGS will not be excluded.

Sponsors & Collaborators

• Everett Meyer: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792-1690, United States

Location

Related Publications (4)

• Scandling JD, Busque S, Dejbakhsh-Jones S, Benike C, Millan MT, Shizuru JA, Hoppe RT, Lowsky R, Engleman EG, Strober S. Tolerance and chimerism after renal and hematopoietic-cell transplantation. N Engl J Med. 2008 Jan 24;358(4):362-8. doi: 10.1056/NEJMoa074191.

  PMID: 18216356 BACKGROUND

• Scandling JD, Busque S, Shizuru JA, Engleman EG, Strober S. Induced immune tolerance for kidney transplantation. N Engl J Med. 2011 Oct 6;365(14):1359-60. doi: 10.1056/NEJMc1107841. No abstract available.

  PMID: 21991976 BACKGROUND

• Scandling JD, Busque S, Dejbakhsh-Jones S, Benike C, Sarwal M, Millan MT, Shizuru JA, Lowsky R, Engleman EG, Strober S. Tolerance and withdrawal of immunosuppressive drugs in patients given kidney and hematopoietic cell transplants. Am J Transplant. 2012 May;12(5):1133-45. doi: 10.1111/j.1600-6143.2012.03992.x. Epub 2012 Mar 8.

  PMID: 22405058 BACKGROUND

• Jensen KP, Hongo DA, Ji X, Zheng P, Pawar R, Wu TH, Busque S, Scandling JD, Shizuru JA, Lowsky R, Shori A, Dutt S, Waters J, Saraswathula A, Baker J, Tamaresis JS, Lavori P, Negrin R, Maecker H, Engleman EG, Meyer E, Strober S. Development of immunosuppressive myeloid cells to induce tolerance in solid organ and hematopoietic cell transplant recipients. Blood Adv. 2021 Sep 14;5(17):3290-3302. doi: 10.1182/bloodadvances.2020003669.

  PMID: 34432869 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Immune Tolerance; Kidney Transplantation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunomodulation; Immune System Phenomena; Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Stephan Busque, MD,MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 20, 2010
• Study Start: July 14, 2010
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2025
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)