Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine

• Conditions: Chloroquine Retinopathy; Proliferative Nephritis
• Interventions: Drug: Chloroquine; Drug: Hydroxychloroquine

• Registration Number: NCT03687905
• Lead Sponsor: Tanta University

Brief Summary

Evaluation the efficacy of chloroquine and hydroxychloroquine in the treatment of proliferative lupus nephritis class III and IV in children and adolescents and evaluate the side effects of both drugs .

Detailed Description

All patients will fulfill the diagnostic criteria of SLE. The diagnosis of systemic lupus erythematosus is based on clinical and laboratory criteria. The criteria set developed by the American College of Rheumatology (ACR) and diagnosed wih lupus nephritis class III and IV .

Inclusion Criteria:

* Children and adolescents who fulfill diagnostics criteria of SLE and diagnosed with lupus nephritis class III and IV.

* All patients will be received steroids , MMF and Angiotensin Converting Enzyme.

Exclusion Criteria:

* Patients diagnosed with lupus nephritis class I,II,V and VI.

* Patients received Cyclophosphamide in stead of MMF.

Study Timeline

• Status Verified: 2018-09
• Study Start: 2018-09-18
• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-25
• Last Update Submitted: 2018-09-25
• Study First Posted: 2018-09-27
• Last Update Posted: 2018-09-27
• Primary Completion: 2019-03-31
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children and adolescents who fulfill diagnostics criteria of SLE and diagnosed with lupus nephritis class III and IV.
• All patients will be received steroids , MMF and Angiotensin Converting Enzyme.

Exclusion Criteria

• Patients diagnosed with lupus nephritis class I,II,V and VI.
• Patients received Cyclophosphamide in stead of MMF.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lupus nephritis III or IV/chloroquine	Chloroquine	receiving chloroquine with daily dose 5 mg/kg
Lupus nephritis III or IV/hydroxychloroquine	Hydroxychloroquine	receiving hydroxycholorquine with daily dose 5 mg/kg

Primary Outcome Measures

Name	Time	Method
Fundus examination as screening test	12 months	Detection of chloroquine and hydroxychloroquine related retinal toxicity at early stage.

Trial Locations

Locations (1)

Fatma Gheet; 🇪🇬 Tanta, Egypt