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Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine

Sponsor
Tanta University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03687905
Collaborator
(none)
60
Enrollment
1
Location
12.4
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparative Study Between Chloroquine and Hydroxychloroquine as Therapeutic Modalities for Children and Adolescents With Proliferative Lupus Nephritis
Actual Study Start Date :
Sep 18, 2018
Anticipated Primary Completion Date :
Mar 31, 2019
Anticipated Study Completion Date :
Sep 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Lupus nephritis III or IV/chloroquine

receiving chloroquine with daily dose 5 mg/kg

Drug: Chloroquine
group1 received chloroquine .
Other Names:
  • alexoquine

    		•
    Lupus nephritis III or IV/hydroxychloroquine

    receiving hydroxycholorquine with daily dose 5 mg/kg

    Drug: Hydroxychloroquine
    Group 2 received hydroxychloroquine
    Other Names:
  • hydroquine

    		•
    Systemic lupus erythematosus

    not received hydroxychloroquine nor chloroquine .

    Outcome Measures

    Primary Outcome Measures

    1. Fundus examination as screening test [12 months]

      Detection of chloroquine and hydroxychloroquine related retinal toxicity at early stage.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 18 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fatma Gheet Tanta Egypt

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Principal Investigator: Fatma S Gheet, M.B.,BCh, Tanta University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fatma Sayed Ahmed Gheet, Resident Pediatercian, Tanta University
    ClinicalTrials.gov Identifier:
    NCT03687905
    Other Study ID Numbers:
    • Fatma
    First Posted:
    Sep 27, 2018
    Last Update Posted:
    Sep 27, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Nephritis
    Lupus Nephritis
    Hydroxychloroquine
    Chloroquine

    Study Results

    No Results Posted as of Sep 27, 2018