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Comparison of Low Dose Versus High Dose Cyclophosphamide as Induction Therapy in the Treatment of Lupus Nephritis

NCT02645565 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2017-03-06

No results posted yet for this study

Summary

This study will be conducted to find out whether low dose or high dose cyclophosphamide therapy is effective in the treatment of proliferative lupus nephritis.It will also compare the side effects and risks of infection in low dose and high dose cyclophosphamide group. Half of the participants will receive a low dose cyclophosphamide for 3 months and half will receive high dose cyclophosphamide therapy monthly for 6 months followed by azathioprine 2 mg/kg.

Conditions

Interventions

DRUG

Cyclophosphamide

Cyclophosphamide is an alkylating agent used for the treatment of lupus nephritis.

DRUG

Azathioprine

azathioprine will be given at 2 mg/kg.

DRUG

Methylprednisolone

Each treatment arm shall receive 1 gm methylprednisolone pulse for 3 days followed by prednisolone 1 mg/kg for 4 weeks and tapered 5 mg every 2 weekly ,to maintain 7.5 mg dose daily

Sponsors & Collaborators

  • Jawaharlal Institute of Postgraduate Medical Education & Research

    lead OTHER_GOV

Principal Investigators

  • Dr. Vir Singh Negi, DM · Jawaharlal Institute of Postgraduate Medical Education & Research

  • Dr. Sonal Mehra, MD · Jawaharlal Institute of Postgraduate Medical Education & Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02645565 on ClinicalTrials.gov