Low-dose Combination of Mycophenolate Mofetil (MMF) and Tacrolimus (Tac) for Refractory Lupus Nephritis

NCT ID: NCT01203709

Last Updated: 2014-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-02-28

Brief Summary

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A trial of combination of two drugs for the treatment of refractory lupus nephritis.

Detailed Description

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Low-dose combination of mycophenolate mofetil and tacrolimus for refractory lupus nephritis: a 12-month prospective study

Conditions

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Lupus Nephritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combination treatment

treatment arm

Group Type EXPERIMENTAL

low dose combination of MMF and Tac

Intervention Type DRUG

mycophenolate mofetil 500mg BID + tacrolimus 2mg BID

Interventions

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low dose combination of MMF and Tac

mycophenolate mofetil 500mg BID + tacrolimus 2mg BID

Intervention Type DRUG

Other Intervention Names

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Cellcept and Prograf

Eligibility Criteria

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Inclusion Criteria

1. Active nephritis documented by renal biopsy within 24 months of entry;
2. Failure to respond to 2 or more immunosuppressive regimens which consisted of high-dose prednisolone combined with other non-corticosteroid immunosuppressive agents together with ACE inhibitors plus or minus angiotensin receptor blockers (ARB) for at least 4 months for each regimen at the maximally tolerated drug dosages;
3. Serum creatinine (Scr) less than 200umol/L.

Exclusion Criteria

1. Previous intolerance to either MMF/Tac;
2. Scr \>200umol/L;
3. Informed consent unavailable.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tuen Mun Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Chi Chiu Mok

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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CC Mok, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Tuen Mun Hospital, Hong Kong China

Locations

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Tuen Mun Hospital

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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NTWC/CREC/837/10

Identifier Type: -

Identifier Source: org_study_id

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