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Research Study of ATG and Rituximab in Renal Transplantation

NCT01318915 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-11-29

Study results available
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Summary

The purpose of this study is see if a combination of two drugs, (ATG and rituximab), given at the time of the transplant surgery, will help reduce or eliminate the need for long term immunosuppressive medication.

Conditions

  • Renal Transplant Recipients

Interventions

DRUG

ATG

1.5 mg/kg IV infusion on day of transplant, and 3 additional on days 2 through 7 after transplant.

DRUG

Rituximab

375 mg/m\^2 IV infusion on day -6 before transplant and on day 1 after transplant.

DRUG

Tacrolimus

Taken orally. Tacrolimus dose adjusted to maintain target blood levels of 6-10 ng/mL.

DRUG

Sirolimus

Taken orally. Initial dose, 2 mg daily on day 10 post-transplant, subsequently adjusted to achieve trough levels of 8-12 ng/mL through week 56. Sirolimus withdrawal will be initiated between week 56 and week 88 in eligible participants.

DRUG

MMF

1 g twice daily on days 0 through 12

Sponsors & Collaborators

  • Immune Tolerance Network (ITN)

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • James Markmann, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-25
Primary Completion
2016-06-17
Completion
2017-08-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01318915 on ClinicalTrials.gov