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Effects of Rituximab and Mycophenolate Mofetil (MMF) on Highly Sensitized Patients Awaiting Renal Transplant

NCT00446251 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2010-04-06

Study results available
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Summary

This is a 12-month phase 2, prospective, open label study to evaluate the effect of rituximab with mycophenolate mofetil (MMF)on the PRA of 14 highly sensitized patients who just completed an 8 month trial of MMF treatment alone. PRA values obtained at study enrollment and at 6 and 12 months on combined therapy as well as the rates of transplant will be compared and evaluated using descriptive analysis.

Conditions

  • Kidney Failure, Chronic
  • Diabetic Nephropathies
  • Glomerulonephritis, IGA
  • Hypertension, Renal

Interventions

DRUG

Rituximab

Rituximab dose is 1,000 mg given as an IV infusion every two weeks for 2 doses (days 1 and 15).

DRUG

Mycophenolate mofetil (MMF)

Cellcept is continued from prior study, taken 500 - 1,000 mg BID, P.O.

Sponsors & Collaborators

Principal Investigators

  • Connie L Davis, MD · University of Washington

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-04-30
Completion
2008-12-31

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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 NCT00446251 on ClinicalTrials.gov