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Trial record 83 of 146 for:    lupus AND Lupus Nephritis

Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine

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ClinicalTrials.gov Identifier: NCT03687905
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Fatma Sayed Ahmed Gheet, Tanta University

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
Proliferative Nephritis Chloroquine Retinopathy Drug: Chloroquine Drug: Hydroxychloroquine

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 [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Comparative Study Between Chloroquine and Hydroxychloroquine as Therapeutic Modalities for Children and Adolescents With Proliferative Lupus Nephritis
Actual Study Start Date : September 18, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : September 30, 2019


Group/Cohort Intervention/treatment
Lupus nephritis III or IV/chloroquine
receiving chloroquine with daily dose 5 mg/kg
Drug: Chloroquine
group1 received chloroquine .
Other Name: alexoquine

Lupus nephritis III or IV/hydroxychloroquine
receiving hydroxycholorquine with daily dose 5 mg/kg
Drug: Hydroxychloroquine
Group 2 received hydroxychloroquine
Other Name: hydroquine

Systemic lupus erythematosus
not received hydroxychloroquine nor chloroquine .



Primary Outcome Measures :
  1. Fundus examination as screening test [ Time Frame: 12 months ]
    Detection of chloroquine and hydroxychloroquine related retinal toxicity at early stage.



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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes 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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687905


Contacts
Contact: Fatma S Gheet, M.B.,BCh +201148157993 fatmagheet@gmail.com

Locations
Egypt
Fatma Gheet Recruiting
Tanta, Egypt
Contact: Fatma S Gheet, M.B.,BCh    +201148157993    fatmagheet@gmail.com   
Sponsors and Collaborators
Tanta University
Investigators
Principal Investigator: Fatma S Gheet, M.B.,BCh Tanta University

Responsible Party: Fatma Sayed Ahmed Gheet, Resident Pediatercian, Tanta University
ClinicalTrials.gov Identifier: NCT03687905     History of Changes
Other Study ID Numbers: Fatma
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data is secret.

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
Lupus Erythematosus, Systemic
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Chloroquine
Chloroquine diphosphate
Hydroxychloroquine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action