Proliferative Lupus Nephritis Treatment With Chloroquine... | NCT03687905

Studies
Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine

NCT03687905

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

Sep 27, 2018Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Proliferative Nephritis
Chloroquine Retinopathy

Interventions

Chloroquine
Hydroxychloroquine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 18, 2018Actual

Primary Completion Date

Mar 31, 2019Estimated

Completion Date

Sep 30, 2019Estimated

First Submitted Date

Sep 18, 2018

First Submission Date that Met QC Criteria

Sep 25, 2018

First Posted Date

Sep 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2018

Last Update Posted Date

Sep 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Lupus nephritis III or IV/chloroquine	receiving chloroquine with daily dose 5 mg/kg	Drug: Chloroquine
Lupus nephritis III or IV/hydroxychloroquine	receiving hydroxycholorquine with daily dose 5 mg/kg	Drug: Hydroxychloroquine
Systemic lupus erythematosus	not received hydroxychloroquine nor chloroquine .

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chloroquine	Drug	group1 received chloroquine .	Lupus nephritis III or IV/chloroquine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fatma S Gheet, M.B.,BCh	Contact	+201148157993		fatmagheet@gmail.com

Overall Officials

Name	Affiliation	Role
Fatma S Gheet, M.B.,BCh	Tanta University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fatma Gheet	Recruiting	Tanta			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36752895	Derived	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.

ID	Term
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring