Steroid-Sensitive Nephrotic SyndromeNCT04713410
Comparison of Relapse Rate After 12 Weeks Verses 20 Weeks Steroid Therapy for the Management of First Episode of Steroid Sensitive Nephrotic Syndrome
A study testing Prednisolone in people with Steroid-Sensitive Nephrotic Syndrome, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
All children from 1 to 8 years of age, diagnose with nephrotic syndrome for the first time will be divided into two groups. One group will be given steroids for 12 weeks and other group will receive steroid for 20 weeks. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Steroid-Sensitive Nephrotic Syndrome
- What is being tested?
- Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Dec 2020to 4 Sep 2023
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 1 to 8 years of age,
- Diagnose with nephrotic syndrome for the first time
- Steroid sensitive nephrotic syndrome
Who cannot join
- Steroid resistant nephrotic syndrome
- Steroid dependent nephrotic syndrome
- Syndromic Children
- Children with other co morbidities
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Institute of Medical Sciences
Islamabad, Capital, 44000
Nighat Haider, FCPS, 03212125768, nighathaider@hotmail.com
Jai Krishin, FCPS, 03335094933, jkrishin@gmail.com
About this study
Official title: Comparison of Relapse Rate After 12 Weeks Verses 20 Weeks Steroid Therapy for the Management of First Episode of Steroid Sensitive Nephrotic Syndrome: A Randomized Control Trial at Children Hospital, Pakistan Institute of Medical Sciences, Islamabad
All children from 1 to 8 years of age, diagnose with nephrotic syndrome for the first time will be divided into two groups. One group will be given steroids for 12 weeks and other group will receive steroid for 20 weeks. During the 1 years after completion of steroid course patients will be monitor for the episodes of relapse in both group.
Read the detailed description
All children from 1 to 8 years of age, diagnose with nephrotic syndrome for the first time, at Pakistan Institute of Medical Sciences, Islamabad, from December 2020 to December 2022 will be included in the study.
Sample size was calculated by using WHO sample size calculator keeping level of significance 5%, power of test 90%, P1 21.6%7 and P2 59.3%8. The sample size is turned out to be 34 patients in each group with total of 68 patients.
The patients fulfilling the inclusion criteria will be registered at our nephrology clinic. Patients' bio data along with history and examination will be recorded on a proforma. They will be divided in two groups designated as A and B. Group A will receive steroid for 12 weeks and group B for 20 weeks. For group A regimen will be to administer prednisolone as a single dose of 60 mg/m2 once daily for 6 weeks, then 40 mg/m2 on alternate day for another 6 weeks and then stop. For group B prednisolone will be given as a single dose of 60 mg/m2 once daily for 6 weeks, then 40 mg/m2 on alternate day for another 6 weeks with tapering of 25% of alternate day dose fortnightly. Outcome will be measured in terms of number of relapses in the subsequent 1 years after stopping steroids.
For treatment of relapse Prednisolone will be given in the dose of 60 mg/m2 once daily till urine protein is negative or trace for 3 consecutive days, then 40 mg/m2 on alternate day for 1 month then stop. In case of frequent relapses and steroid dependent cases, relapses will be treated as follows; prednisolone 60 mg/m2 on alternate day till urine protein will be negative for 5days then 40 mg/m2 on alternate day for 1 month then with tapering at the rate of 5 mg fortnightly.
Children with congenital and infantile nephrotic syndrome, persistent hypertension, gross haematuria, family history of nephrotic syndrome and age below 1 year and above 8 years will be excluded from study.
After approval of study from ethical review board, informed consent will be taken from parents. The data obtained will be analyzed using SPSS version 20. The t test will be applied for comparison of mean and chi sqare test for comparison of percentages. The p value less than .05 will be taken as significant.
- Conditions
- Steroid-Sensitive Nephrotic Syndrome
- Being tested
- Prednisolone
- Keywords
- Nephrotic Syndrome, steroid response, relapse
- Medical subject headings
- Nephrotic Syndrome, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Regimen will be to administer prednisolone as a single dose of 60 mg/m2 once daily for 6 weeks, then 40 mg/m2 on alternate day.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Steroids will be given for short duration of time i-e 12 weeks Receives: Drug: Prednisolone |
| Group B | Active comparator | Steroid will be given for longer duration i-e 20 weeks Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate
Relapse rete
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start22 Dec 2020
- Primary completion4 Sep 2022 (estimated)
- Study completion4 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steroid-Sensitive 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nighat Haider, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713410
- Sponsor's protocol ID
- No.F.1-1/2015/ERB/SZABMU/465
- Status last verified
- May 2021
- First submitted
- 14 Jan 2021
- Last updated
- 11 May 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 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Relapse Rate After 12 Weeks Verses 20 Weeks Steroid Therapy for the Management of First Episode of Steroid Sensitive Nephrotic Syndrome: A Randomized Control Trial at Children Hospital, Pakistan Institute of Medical Sciences, Islamabad
- ClinicalTrials.gov ID
- NCT04713410
- Acronym / sponsor ID
- No.F.1-1/2015/ERB/SZABMU/465
- Conditions
- Steroid-Sensitive Nephrotic Syndrome
- Keywords
- Nephrotic Syndrome, steroid response, relapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 4 Sep 2022 (estimated)
- Study completion
- 4 Sep 2023 (estimated)
- First posted
- 19 Jan 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.
All children from 1 to 8 years of age, diagnose with nephrotic syndrome for the first time will be divided into two groups. One group will be given steroids for 12 weeks and other group will receive steroid for 20 weeks. During the 1 years after completion of steroid course patients will be monitor for the episodes of relapse in both group.
Detailed description
All children from 1 to 8 years of age, diagnose with nephrotic syndrome for the first time, at Pakistan Institute of Medical Sciences, Islamabad, from December 2020 to December 2022 will be included in the study.
Sample size was calculated by using WHO sample size calculator keeping level of significance 5%, power of test 90%, P1 21.6%7 and P2 59.3%8. The sample size is turned out to be 34 patients in each group with total of 68 patients.
The patients fulfilling the inclusion criteria will be registered at our nephrology clinic. Patients' bio data along with history and examination will be recorded on a proforma. They will be divided in two groups designated as A and B. Group A will receive steroid for 12 weeks and group B for 20 weeks. For group A regimen will be to administer prednisolone as a single dose of 60 mg/m2 once daily for 6 weeks, then 40 mg/m2 on alternate day for another 6 weeks and then stop. For group B prednisolone will be given as a single dose of 60 mg/m2 once daily for 6 weeks, then 40 mg/m2 on alternate day for another 6 weeks with tapering of 25% of alternate day dose fortnightly. Outcome will be measured in terms of number of relapses in the subsequent 1 years after stopping steroids.
For treatment of relapse Prednisolone will be given in the dose of 60 mg/m2 once daily till urine protein is negative or trace for 3 consecutive days, then 40 mg/m2 on alternate day for 1 month then stop. In case of frequent relapses and steroid dependent cases, relapses will be treated as follows; prednisolone 60 mg/m2 on alternate day till urine protein will be negative for 5days then 40 mg/m2 on alternate day for 1 month then with tapering at the rate of 5 mg fortnightly.
Children with congenital and infantile nephrotic syndrome, persistent hypertension, gross haematuria, family history of nephrotic syndrome and age below 1 year and above 8 years will be excluded from study.
After approval of study from ethical review board, informed consent will be taken from parents. The data obtained will be analyzed using SPSS version 20. The t test will be applied for comparison of mean and chi sqare test for comparison of percentages. The p value less than .05 will be taken as significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: PrednisoloneSteroids will be given for short duration of time i-e 12 weeks |
| Group B | Active comparator | Drug: PrednisoloneSteroid will be given for longer duration i-e 20 weeks |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children 1 to 8 years of age,
- Diagnose with nephrotic syndrome for the first time
- Steroid sensitive nephrotic syndrome
Key exclusion criteria (4 listed)
- Steroid resistant nephrotic syndrome
- Steroid dependent nephrotic syndrome
- Syndromic Children
- Children with other co morbidities
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 |
|---|---|---|
| PrednisoloneRegimen will be to administer prednisolone as a single dose of 60 mg/m2 once daily for 6 weeks, then 40 mg/m2 on alternate day. | Drug | Group A, Group B |
Primary outcome
Relapse rate
Time frame: 2 years
Relapse rete
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisolone in people with Steroid-Sensitive Nephrotic Syndrome, run by Shaheed Zulfiqar Ali Bhutto 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?
The sponsor lists 3 inclusion and 4 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 11 May 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse rate (time frame: 2 years). 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 11 May 2021.