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Comparison of two Steroid dose regimen in Lupus Nephritis

COMPARISON OF TWO STEROID REGIMENS IN INDUCTION THERAPY OF PROLIFERATIVE LUPUS NEPHRITIS-A RANDOMISED CONTROLLED TRIAL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/01/006488
Enrollment
60
Registered
2016-01-07
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: Oral Prednisolone (0.5 mg/kg/day): intravenous methyl prednisolone (750 mg) for 3 days after which they would receive 0.5 mg/kg/day of oral prednisolone for a period of 8 weeks followed

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • With a diagnosis of SLE as per American College of Rheumatology (ACR) criteria • Biopsy proved LN (ISN/RPS class III, IV, III+V or IV+V)

Exclusion criteria

Exclusion criteria: â?? Pregnancy/lactation â?? Presence of crescents > 50% of the sampled glomeruli â?? On-going infection â?? Hepatitis B, C or human immunodeficiency virus-I/II infection â?? Prior use of steroids/ immunosuppressive medication for any indication â?? Serum creatinine > 2 mg/dl â?? Neurological or pulmonary lupus â?? History of Diabetes mellitus (DM) â?? Abnormal liver function tests â?? Drug-induced lupus

Design outcomes

Primary

MeasureTime frame
Treatment responseTimepoint: 6 months

Secondary

MeasureTime frame
Complete/partial remission, SELENA-SLEDAI score, QOL, serological remission and adverse events.Timepoint: 6 months

Countries

India

Contacts

Public ContactRaja Ramachandran

PGIMER

sharma.joyita4@gmail.com9878169746

Outcome results

None listed

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