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A study to compare the efficacy of cyclophosphamide versus multi-drug therapy in the treatment of lupus nephritis

RANDOMIZED CONTROLLED TRIAL OF MULTITARGETTED THERAPY VERSUS LOW-DOSE INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF LUPUS NEPHRITIS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/05/008697
Enrollment
88
Registered
2017-05-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Lupus Nephritis

Interventions

Intervention1: Multitargeted Therapy: MMF will be given in doses of 1 gm/day in 2 divided doses and TAC will be given at 0.1 mg/kg/day to target a trough level of 4-7 ng/ml.. MMF and TAC will be take

Sponsors

Director
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. SLE diagnosis by ACR criteria 2. Lupus nephritis class III, IV, V, a combination of III+V or IV+V 3. Serum creatinine

Exclusion criteria

Exclusion criteria: 1. Severe proliferative lupus nephritis on Histopathologic Examination (eg. Crescents in >50% of the glomeruli) 2. Ongoing infection 3. Pregnant females 4. Low TLC count 5. Previously received immunosuppressive treatment 6. Patient not giving consent

Design outcomes

Primary

MeasureTime frame
1.Decrease in proteinuria, defined as decrease in the urine protein/creatinine ratio to 3 in subjects with baseline nephrotic range proteinuria (�3 urine protein/creatinine ratio) or decrease in the urine protein/creatinine ratio by �50% in subjects with sub-nephrotic proteinuria (3 urine protein/creatinine ratio). This ratio is on the basis of 24 h urine collection 2.Stabilization of serum creatinine (i.e., a week 24 serum creatinine level ±25% of baseline) or improvement Timepoint: 24 week

Secondary

MeasureTime frame
Complete renal remission (defined as a return to normal serum creatinine, proteinuria â?¤500mg/24hr and inactive urine sediment) and Adverse eventsTimepoint: 24 week

Countries

India

Contacts

Public ContactKrishan Lal Gupta

Department of Nephrology

klgupta@hotmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026