Rituximab Therapy for Patients on Kidney Transplant Waiting List With Positive Donor Specific Crossmatch to Living Donor

NCT00476515 | Withdrawn Phase 1 DMC

• 1 other identifier: 2006P002059
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary Objectives:

• Conversion of a positive donor specific cross-match to a living donor to a negative cross-match thereby allowing successful renal transplantation.
• Transplant success or failure following the desensitization protocol.
• Determination of the effect of rituximab on the kinetics of donor specific antibodies (DSA).
• Determination of the effect of rituximab on the kinetics of B-cell subpopulations in peripheral blood and/or secondary lymphoid organs (lymph node biopsies at time of transplant, if available) in both responders and non-responders using flow cytometry and/or immunohistochemistry. Secondary Objectives:
• Decrease in incidence of humoral rejection to less than 50 % at 1 year.

Conditions

Kidney Insufficiency

Keywords

Kidney transplantation; Donor specific antibodies; Positive cross match

Outcome Measures

Primary Outcomes (1)

• Subjects who convert to a negative donor specific crossmatch or eliminate donor specific antibody will be considered a TREATMENT SUCCESS and will undergo target living donor transplantation in 3-5 days

  4 weeks after the final dose of Rituximab

Study Arms (1)

Rituximab

EXPERIMENTAL

this study has only one arm as treatment group.

Drug: Rituximab

Interventions

Rituximab DRUG

the recommended dosage of Rituximab is 375 mg/m2 given as an IV infusion once weekly for four doses (days 1, 8, 15, and 22).

Also known as: Rituxan

Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active status on a kidney transplant waiting list for over 2 years
• Donor specific antibody titer \<= 1:128 (Class I, Class II or both) by cytotoxicity
• Signed and dated informed consent
• Age ≥ 18 years
• Positive cross-match against a living donor

You may not qualify if:

• Donor specific antibody titer greater than 1:128 (Class I, Class II or both) by cytotoxicity
• Inactive status on a kidney transplant list
• Treatment with any investigational agent within 4 weeks of screening or 5-half-lives of the investigational drug (whichever is longer)
• Receipt of a live vaccine within 4 weeks prior to randomization
• Previous Treatment with Rituximab (MabThera/Rituxan)
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• Positive history of HIV
• Positive history of Hepatitis B and/or Hepatitis C
• History of recurrent significant infection or history of recurrent bacterial infections
• Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
• History of drug, alcohol, or chemical abuse within 6 months prior to screening
• Pregnancy (a negative serum or urine pregnancy test should be performed for all women of childbearing potential within 7 days of treatment)
• Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment
• Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• History of psychiatric disorder

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Biogen: collaborator
• Genentech, Inc.: collaborator

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Nina Tolkoff-Rubin, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 18, 2007
• First Posted: May 22, 2007
• Study Start: March 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: October 23, 2023

Record last verified: 2023-10