Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine

Chloroquine Retinopathy Clinical Trial

Official title:

Comparative Study Between Chloroquine and Hydroxychloroquine as Therapeutic Modalities for Children and Adolescents With Proliferative Lupus Nephritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03687905
• Other study ID #: Fatma
• Status: Recruiting
• Start date: September 18, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: September 2018
• Source: Tanta University
• Contact: Fatma S Gheet, M.B.,BCh
• Phone: +201148157993
• Email: fatmagheet[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2019
• Est. primary completion date: March 31, 2019
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chloroquine Retinopathy
• Lupus Nephritis
• Nephritis
• Proliferative Nephritis

Intervention

Drug:
• Chloroquine
group1 received chloroquine .
• Hydroxychloroquine
Group 2 received hydroxychloroquine

Locations

Country	Name	City	State
Egypt	Fatma Gheet	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fundus examination as screening test	Detection of chloroquine and hydroxychloroquine related retinal toxicity at early stage.	12 months