MedTrace Logo

A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis

NCT02081183 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-07-17

Study results available
· View outcomes & findings →

Summary

This study will compare the efficacy of CellCept \[0.5-2 grams per day (g/day) orally (p.o.)\] and cyclophosphamide \[0.5-1 grams per square meter (g/m2) quarterly\] as maintenance treatment for patients with lupus nephritis. All patients will receive induction treatment with cyclophosphamide (0.5-1g/m2 monthly) for 6 months, and will then be randomized to the maintenance phase of the study for a further 6 months, followed by 6 months of treatment-free follow-up. The anticipated time on study treatment is 12 months.

Conditions

Interventions

DRUG

Mycophenolate mofetil (MMF)

1 g/day, PO BID for 2 weeks; 1.5 g/day PO TID for the next 2 weeks; and 2 g/day PO BID for the remainder of the Maintenance Phase.

DRUG

Cyclophosphamide, Maintenance Phase

0.5-1 g/m\^2 IV pulse once every 3 months

DRUG

Cyclophosphamide, Induction Phase

0.5 - 1 g/m\^2 IV pulse once per month

DRUG

Prednisone

1 mg/kg PO once per day; reduced by 5 mg every 2 weeks up to 20 mg/day; followed by a reduction of 2.5 mg every 2 weeks until reaching the maintenance phase of 10 mg/day.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Venezuela

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT02081183 on ClinicalTrials.gov