Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine

NCT ID: NCT03687905

Last Updated: 2018-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-18

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Proliferative Nephritis Chloroquine Retinopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lupus nephritis III or IV/chloroquine

receiving chloroquine with daily dose 5 mg/kg

Chloroquine

Intervention Type DRUG

group1 received chloroquine .

Lupus nephritis III or IV/hydroxychloroquine

receiving hydroxycholorquine with daily dose 5 mg/kg

Hydroxychloroquine

Intervention Type DRUG

Group 2 received hydroxychloroquine

Systemic lupus erythematosus

not received hydroxychloroquine nor chloroquine .

No interventions assigned to this group

Interventions

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Chloroquine

group1 received chloroquine .

Intervention Type DRUG

Hydroxychloroquine

Group 2 received hydroxychloroquine

Intervention Type DRUG

Other Intervention Names

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alexoquine hydroquine

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Sayed Ahmed Gheet

Resident Pediatercian

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatma S Gheet, M.B.,BCh

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

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Fatma Gheet

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Fatma S Gheet, M.B.,BCh

Role: CONTACT

+201148157993

Facility Contacts

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Fatma S Gheet, M.B.,BCh

Role: primary

+201148157993

References

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Gheet FS, Dawoud HE, El-Shahaby WA, Elrifaey SM, Abdelnabi HH. Hydroxychloroquine in children with proliferative lupus nephritis: a randomized clinical trial. Eur J Pediatr. 2023 Apr;182(4):1685-1695. doi: 10.1007/s00431-023-04837-0. Epub 2023 Feb 8.

Reference Type DERIVED
PMID: 36752895 (View on PubMed)

Other Identifiers

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Fatma

Identifier Type: -

Identifier Source: org_study_id

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