Proliferative NephritisNCT03687905
Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine
An observational study of Proliferative Nephritis and Chloroquine Retinopathy, run by Tanta University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Proliferative Nephritis, Chloroquine Retinopathy
- What is being tested?
- Chloroquine and Hydroxychloroquine
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Sep 2018to 30 Sep 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- Patients diagnosed with lupus nephritis class I,II,V and VI.
- Patients received Cyclophosphamide in stead of MMF.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Fatma Gheet
Tanta
Fatma S Gheet, M.B.,BCh, +201148157993, fatmagheet@gmail.com
About this study
Official title: 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 .
Read the 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.
- Conditions
- Proliferative Nephritis, Chloroquine Retinopathy
- Being tested
- Chloroquine, Hydroxychloroquine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroquineDrug
Also called alexoquine
group1 received chloroquine .
Also called hydroquine
Group 2 received hydroxychloroquine
| Study group | Role | What they receive |
|---|---|---|
| Lupus nephritis III or IV/chloroquine | receiving chloroquine with daily dose 5 mg/kg Receives: Drug: Chloroquine | |
| Lupus nephritis III or IV/hydroxychloroquine | receiving hydroxycholorquine with daily dose 5 mg/kg Receives: Drug: Hydroxychloroquine | |
| Systemic lupus erythematosus | not received hydroxychloroquine nor chloroquine . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fundus examination as screening test
Detection of chloroquine and hydroxychloroquine related retinal toxicity at early stage.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start18 Sep 2018
- Primary completion31 Mar 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proliferative NephritisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Sayed Ahmed Gheet, Tanta University
- Investigators
- Fatma S Gheet, M.B.,BCh, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687905
- Sponsor's protocol ID
- Fatma
- Status last verified
- Sep 2018
- First submitted
- 18 Sep 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is secret.
Publications
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.
PubMed 36752895
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Chloroquine and Hydroxychloroquine as Therapeutic Modalities for Children and Adolescents With Proliferative Lupus Nephritis
- ClinicalTrials.gov ID
- NCT03687905
- Acronym / sponsor ID
- Fatma
- Conditions
- Proliferative Nephritis, Chloroquine Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lupus nephritis III or IV/chloroquine | – | Drug: Chloroquinereceiving chloroquine with daily dose 5 mg/kg |
| Lupus nephritis III or IV/hydroxychloroquine | – | Drug: Hydroxychloroquinereceiving hydroxycholorquine with daily dose 5 mg/kg |
| Systemic lupus erythematosus | – | –not received hydroxychloroquine nor chloroquine . |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients diagnosed with lupus nephritis class I,II,V and VI.
- Patients received Cyclophosphamide in stead of MMF.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChloroquineAlso: alexoquinegroup1 received chloroquine . | Drug | Lupus nephritis III or IV/chloroquine |
| HydroxychloroquineAlso: hydroquineGroup 2 received hydroxychloroquine | Drug | Lupus nephritis III or IV/hydroxychloroquine |
Primary outcome
Fundus examination as screening test
Time frame: 12 months
Detection of chloroquine and hydroxychloroquine related retinal toxicity at early stage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Derived from this study: PubMed 36752895Gheet 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.
- Individual participant dataSharing planned: No. Individual participant data is secret.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma S Gheet, M.B.,BCh principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proliferative Nephritis and Chloroquine Retinopathy, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma S Gheet, M.B.,BCh (+201148157993, fatmagheet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fundus examination as screening test (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03687905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.