The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets in Patients With Proliferative Lupus Nephritis

NCT ID: NCT02954939

Last Updated: 2024-12-16

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

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2028-12-31

Brief Summary

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This study investigated the effect of mycophenolate mofetil and cyclosphosphamide on lymphocyte subsets in patients with proliferative lupus nephritis. Patients with biopsy-proven Class III/IV+/-V LN were randomized to received: 1) prednisolone (0.8mg/kg/day) plus CTX (1.5-2mg/kg/d) for 6 months) followed by Azathioprine (AZA) (1-1.5mg/kg/d) maintenance; OR 2) prednisolone (0.8mg/kg/d) plus MMF (1g bd) for 6 months, followed by MMF (tapered according to clinical status) as maintenance. The lymphocyte subsets and serum cytokine profiles will be measured at 4-, 12-, and 24-, 36- and 48 weeks after induction treatment. The lymphocyte subsets and serum cytokine profiles will be compared between the two treatment regimens, and also correlated with subsequent risk of relapse.

Detailed Description

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This study investigated the effect of mycophenolate mofetil and cyclosphosphamide on lymphocyte subsets in patients with proliferative lupus nephritis. Patients with biopsy-proven Class III/IV+/-V LN were randomized to received: 1) prednisolone (0.8mg/kg/day) plus CTX (1.5-2mg/kg/d) for 6 months) followed by Azathioprine (AZA) (1-1.5mg/kg/d) maintenance; OR 2) prednisolone (0.8mg/kg/d) plus MMF (1g bd) for 6 months, followed by MMF (tapered according to clinical status) as maintenance. The lymphocyte subsets and serum cytokine profiles will be measured at 4-, 12-, and 24-, 36- and 48 weeks after induction treatment. The lymphocyte subsets and serum cytokine profiles will be compared between the two treatment regimens, and also correlated with subsequent risk of relapse.

Conditions

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Lupus Nephritis

Keywords

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lupus nephritis lymphocyte subsets cytokines mycophenolate mofetil cyclophosphamide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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MMF-MMF

Class III/IV+V LN patients who receive prednisolone (PRED) (0.8mg/kg/d) plus mycophenolate mofetil (MMF) (1g bd) as induction-maintenance therapy

Group Type ACTIVE_COMPARATOR

MMF-MMF

Intervention Type DRUG

Class III/IV+/-V lupus nephritis patients to receive PRED+MMF

CTX-AZA

Class III/IV+V LN patients who receive prednisolone (PRED) (0.8mg/kg/d) plus Cyclophosphamide (CTX) (1.5-2mg/kg/d) followed by Azathioprine (AZA) (1-1.5mg/kg/d) as induction-maintenance therapy

Group Type PLACEBO_COMPARATOR

CTX-AZA

Intervention Type DRUG

Class III/IV+/-V lupus nephritis patients to receive PRED+CTX followed by AZA

Interventions

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MMF-MMF

Class III/IV+/-V lupus nephritis patients to receive PRED+MMF

Intervention Type DRUG

CTX-AZA

Class III/IV+/-V lupus nephritis patients to receive PRED+CTX followed by AZA

Intervention Type DRUG

Other Intervention Names

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PRED; MMF PRED; CTX; AZA

Eligibility Criteria

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Inclusion Criteria

\- 1. Patients with biopsy proven Class III/IV+/-V LN (ISN/RPS classification) and active nephritis as indicated by an increase of proteinuria \>1g/day and/or rise in serum creatinine by \>15% compared with baseline, with or without serological reactivation.

2\. Willing to give informed consent

Exclusion Criteria

1. Patients who have received calcineurin inhibitors or proliferation signal inhibitors as maintenance immunosuppression in the preceding 3 months
2. Patients have received biologics therapy (e.g. rituximab, abatacept) in the preceding 12 months
3. Patients who are pregnant or lactating
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Desmond YAP, MD (HK)

Role: CONTACT

Phone: 22554385

Email: [email protected]

Facility Contacts

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Desmond Yap, MD (HK)

Role: primary

Other Identifiers

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UW12-389

Identifier Type: -

Identifier Source: org_study_id