Nephrotic SyndromeNCT04818723
Role of Montelukast in Preventing Relapse in Childhood Idiopathic Nephrotic Syndrome
A study testing Montelukast in people with Nephrotic Syndrome, run by Nishtar Medical University at 1 site in Pakistan.
Trial summary
The investigators planned this research to elucidate if there is any efficacy of montelukast, a leukotriene receptor antagonist, in steroid sensitive childhood onset NS to help prevent relapses. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- Montelukast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2019to 30 May 2020
- Phase
- Interventional
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria:A total of 106 children aged 1-10 years with idiopathic nephrotic syndrome were enrolled
-
Exclusion Criteria: - Patients having Steroid resistant nephrotic syndrome (SRNS) or those having nephrotic syndrome with atypical features or Secondary cause were excluded.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Pediatric Nephrology, The Children's Hospital and Institute of Child Health
Multan, PPunjab
About this study
The investigators planned this research to elucidate if there is any efficacy of montelukast, a leukotriene receptor antagonist, in steroid sensitive childhood onset NS to help prevent relapses. This study was done to know the role of leukotriene receptor antagonist (LTRA) montelukast in preventing relapses in idiopathic childhood nephrotic syndrome (NS)
Read the detailed description
A quasi-experimental study, done at Department of Pediatric Nephrology at the Children's Hospital \& the Institute of Child Health, Multan. A total of 96 patients aged 1-10 years with steroid sensitive Idiopathic NS were assigned into two groups (48 patients in each group). The case group received montelukast 5mg daily at bed time while the control group was not given montelukast. Steroid treatment protocol was the same for the two groups as per institutional guidelines. Patients were monitored and followed for the response to treatment and evidence of relapse over the study period (minimum 12 months).
- Conditions
- Nephrotic Syndrome
- Being tested
- Montelukast
- Keywords
- Leukotriene antagonists, Nephrotic syndrome, Steroid
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
We wanted to know the role of leukotriene receptor antagonist (LTRA) montelukast in preventing relapses in idiopathic childhood nephrotic syndrome (NS)
| Study group | Role | What they receive |
|---|---|---|
| Montelukast Group | Experimental | 53 in Case Group (given montelukast 5mg at bed time). All patients were induced with prednisolone 2mg/kg single morning dose with breakfast for total 4 weeks. Patients who did not achieve remission after 4 weeks' full dose were labeled steroid resistant nephrotic syndrome (SRNS). Children with steroid sensitive nephrotic syndrome SSNS were further treated by prednisolone 1.5 mg/kg single morning dose with breakfast every other day for the next 4 weeks. Prednisolone was then tapered by reducing 25% dose fortnightly and completely stopped in 8 weeks. Patients in the Case Group continued taking montelukast after stopping steroids. All patients were followed up every 4-8 weeks for a minimum of 12 months to look for response to treatment, side effects of medications, other co-morbidities, and the number of relapses. Relapses were treated with repeat prednisolone doses according to the protocol of treatment for relapse. Receives: Drug: Montelukast |
| Placebo Group | Placebo comparator | Patients in this groups were induced with prednisolone 2mg/kg single morning dose with breakfast for total 4 weeks. Patients who did not achieve remission after 4 weeks' full dose were labeled steroid resistant nephrotic syndrome (SRNS). Children with steroid sensitive nephrotic syndrome SSNS were further treated by prednisolone 1.5 mg/kg single morning dose with breakfast every other day for the next 4 weeks. Prednisolone was then tapered by reducing 25% dose fortnightly and completely stopped in 8 weeks. Patients in the Case Group continued taking montelukast after stopping steroids. All patients were followed up every 4-8 weeks for a minimum of 12 months to look for response to treatment, side effects of medications, other co-morbidities, and the number of relapses. Relapses were treated with repeat prednisolone doses according to the protocol of treatment for relapse. Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of relapse in idiopathic childhood nephrotic syndrome
Relapse was labeled as recurrence of proteinuria 3+ or more for 3 consecutive days with or without edema
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Feb 2019
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- During the study period, adopting non-probability consecutive sampling method, patients were assigned into two groups; 53 in Case Group (given montelukast 5mg at bed time) and 53 in Control Group (given no montelukast).
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashim Raza, Nishtar Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818723
- Sponsor's protocol ID
- NishtarMU
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Montelukast in Preventing Relapse in Childhood Idiopathic Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT04818723
- Acronym / sponsor ID
- NishtarMU
- Conditions
- Nephrotic Syndrome
- Keywords
- Leukotriene antagonists, Nephrotic syndrome, Steroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 26 Mar 2021 (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.
The investigators planned this research to elucidate if there is any efficacy of montelukast, a leukotriene receptor antagonist, in steroid sensitive childhood onset NS to help prevent relapses. This study was done to know the role of leukotriene receptor antagonist (LTRA) montelukast in preventing relapses in idiopathic childhood nephrotic syndrome (NS)
Detailed description
A quasi-experimental study, done at Department of Pediatric Nephrology at the Children's Hospital \& the Institute of Child Health, Multan. A total of 96 patients aged 1-10 years with steroid sensitive Idiopathic NS were assigned into two groups (48 patients in each group). The case group received montelukast 5mg daily at bed time while the control group was not given montelukast. Steroid treatment protocol was the same for the two groups as per institutional guidelines. Patients were monitored and followed for the response to treatment and evidence of relapse over the study period (minimum 12 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- During the study period, adopting non-probability consecutive sampling method, patients were assigned into two groups; 53 in Case Group (given montelukast 5mg at bed time) and 53 in Control Group (given no montelukast).
| Arm | Type | Receives |
|---|---|---|
| Montelukast Group | Experimental | Drug: Montelukast53 in Case Group (given montelukast 5mg at bed time). All patients were induced with prednisolone 2mg/kg single morning dose with breakfast for total 4 weeks. Patients who did not achieve remission after 4 weeks' full dose were labeled steroid resistant nephrotic syndrome (SRNS). Children with steroid sensitive nephrotic syndrome SSNS were further treated by prednisolone 1.5 mg/kg single morning dose with breakfast every other day for the next 4 weeks. Prednisolone was then tapered by reducing 25% dose fortnightly and completely stopped in 8 weeks. Patients in the Case Group continued taking montelukast after stopping steroids. All patients were followed up every 4-8 weeks for a minimum of 12 months to look for response to treatment, side effects of medications, other co-morbidities, and the number of relapses. Relapses were treated with repeat prednisolone doses according to the protocol of treatment for relapse. |
| Placebo Group | Placebo comparator | Drug: MontelukastPatients in this groups were induced with prednisolone 2mg/kg single morning dose with breakfast for total 4 weeks. Patients who did not achieve remission after 4 weeks' full dose were labeled steroid resistant nephrotic syndrome (SRNS). Children with steroid sensitive nephrotic syndrome SSNS were further treated by prednisolone 1.5 mg/kg single morning dose with breakfast every other day for the next 4 weeks. Prednisolone was then tapered by reducing 25% dose fortnightly and completely stopped in 8 weeks. Patients in the Case Group continued taking montelukast after stopping steroids. All patients were followed up every 4-8 weeks for a minimum of 12 months to look for response to treatment, side effects of medications, other co-morbidities, and the number of relapses. Relapses were treated with repeat prednisolone doses according to the protocol of treatment for relapse. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| MontelukastWe wanted to know the role of leukotriene receptor antagonist (LTRA) montelukast in preventing relapses in idiopathic childhood nephrotic syndrome (NS) | Drug | Montelukast Group, Placebo Group |
Primary outcome
Prevention of relapse in idiopathic childhood nephrotic syndrome
Time frame: 1 year
Relapse was labeled as recurrence of proteinuria 3+ or more for 3 consecutive days with or without edema
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montelukast in people with Nephrotic Syndrome, run by Nishtar Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 26 Mar 2021. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of relapse in idiopathic childhood nephrotic syndrome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2021.