Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine

September 25, 2018 updated by: Fatma Sayed Ahmed Gheet, Tanta University

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

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Tanta, Egypt
        • Recruiting
        • Fatma Gheet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

• 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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fundus examination as screening test
Time Frame: 12 months
Detection of chloroquine and hydroxychloroquine related retinal toxicity at early stage.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2018

Primary Completion (Anticipated)

March 31, 2019

Study Completion (Anticipated)

September 30, 2019

Study Registration Dates

First Submitted

September 18, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

September 27, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fatma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data is secret.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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