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OpenTrials
Completed

NCT Number: NCT01780454

Renal Allograft Tolerance Through Mixed Chimerism

This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a haplo-identical related 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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Male or female 18-60 years of age
  • Candidate for a living-donor renal allograft with a one haplotype identical donor identified.
  • First or second transplant with either a living donor or cadaveric transplant as the first transplant.
  • Positive serologic testing for EBV indicating past exposure.

Key Exclusion Criteria:

  • ABO blood group-incompatible renal allograft.
  • Evidence of anti-HLA antibody within 60 days prior to transplant as assessed by routine methodology (AHG and/or ELISA)
  • Positive testing for: HIV, hepatitis B core antigen, or hepatitis C virus or positivity for hepatitis B surface antigen.
  • Cardiac ejection fraction < 40% or clinical evidence of insufficiency.
  • History of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as focal segmental glomerulosclerosis, type I or II nonproliferative glomerulonephritis).
  • Prior dose-limiting radiation therapy.
  • Abnormal (>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT).
  • The presence of any medical condition that the investigator deems incompatible with participation in the trial.

Treatment and study plan

MEDI-507

Drug

T-Cell Depleting Agent

Rituximab

Drug

B-Cell Depleting Agent

Total Body Irradiation

Radiation

Bone Marrow Depletion

Thymic Irradiation

Radiation

Primary outcomes

  1. Successful Withdrawal of Immunosuppressive Therapy

    Time frame: 5 years

    The primary endpoint is induction of transient mixed chimerism and renal allograft tolerance without "engraftment syndrome" or "acute kidney injury"

Secondary outcomes

  1. Number of Participants With Engraftment Syndrome

    Time frame: 5 Years

    Constellation of symptoms known "Engraftment Syndrome"

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2020
First posted
Jan 31, 2013
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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