Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635720
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
REduced-dose Steroid PrOtocol for Childhood Nephrotic SyndromE RESPONSE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
REduced-dose Steroid PrOtocol for Childhood Nephrotic SyndromE RESPONSE a Pilot Open-label Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESPONSE
Brief Summary:
This is a pilot feasibility study for a proposed full-scale randomized controlled trial to evaluate the effectiveness and safety of a reduced-dose oral prednisone steroids regimen to treat childhood steroid-sensitive nephrotic syndrome relapses versus standard-dose prednisone ie usual standard of care
This internal pilot study is a single-center open-label randomized controlled trial at The Hospital for Sick Children Toronto ON Canada The primary objective of this pilot study is to determine the feasibility safety and resources needed to conduct the future full-scale randomized controlled trial
This internal pilot study is a single-center open-label randomized controlled trial at The Hospital for Sick Children Toronto ON Canada The primary objective of this pilot study is to determine the feasibility safety and resources needed to conduct the future full-scale randomized controlled trial
Detailed Description:
Study design
This is a pilot study for a planned multi-center Bayesian adaptive non-inferiority RCT Figure 1 This planned multi-center RCT will require additional funding which we will apply for if feasibility is shown by this pilot This pilot is a single-center SickKids open-label RCT comparing reduced vs standard-dose steroids to treat nephrotic syndrome relapses
Study population
We will include children 1-18 years from Ontario Canada that are diagnosed with idiopathic SSNS and present in relapse 3 dipstick protein or proteincreatinine ratio 200mg mmol for 3 consecutive days We will exclude children that have received gt2 days of standard-dose prednisone are on maintenance high-dose prednisone gt03mgkg per day or gt06mgkg alternate days have relapsed within the past 6 weeks have grade 3 peripheral edema ie moderate-severe are hospitalized have stage 2 acute kidney injury or have thromboembolism Children receiving other steroid-sparing immunosuppressives are eligible but target drug levels will remain constant until the 2-week visit No additional laboratory or imaging tests are needed to maximize recruitment
Interventions
Reduced-dose steroids intervention oral prednisone 30mgm2 1mgkg max 40mg daily until remission then 20mgm2 066mgkg max 25mg on alternate days for four weeks
Standard-dose steroids control oral prednisone 60mgm2 2mgkg max 60mg daily until remission then 40mgm2 15mgkg max 50mg on alternate days for four weeks
Randomization 11 using permuted blocks If a participant does not achieve remission by 2-weeks develops symptomatic edema stage 2 acute kidney injury or thromboembolism they will be escalated to standard-dose steroids
Outcomes
The primary outcome is recruitment rate number enrolled per month since it is the greatest anticipated barrier to RCT feasibility Other feasibility tolerability and safety outcomes are listed in Table 1 The pilot study will test case report forms data management quality control and training systems We will estimate treatment effect for the full-scale RCTs primary outcome complete remission without steroid dose escalation by 2-weeks to re-estimate sample size and evaluate full-scale RCT feasibility
Sample size
For this pilot study we will recruit 50 children 25 per arm which is 15 of the estimated sample size of the full-scale RCT Sample size for this pilot must be adequate to assess RCT feasibility
This is a pilot study for a planned multi-center Bayesian adaptive non-inferiority RCT Figure 1 This planned multi-center RCT will require additional funding which we will apply for if feasibility is shown by this pilot This pilot is a single-center SickKids open-label RCT comparing reduced vs standard-dose steroids to treat nephrotic syndrome relapses
Study population
We will include children 1-18 years from Ontario Canada that are diagnosed with idiopathic SSNS and present in relapse 3 dipstick protein or proteincreatinine ratio 200mg mmol for 3 consecutive days We will exclude children that have received gt2 days of standard-dose prednisone are on maintenance high-dose prednisone gt03mgkg per day or gt06mgkg alternate days have relapsed within the past 6 weeks have grade 3 peripheral edema ie moderate-severe are hospitalized have stage 2 acute kidney injury or have thromboembolism Children receiving other steroid-sparing immunosuppressives are eligible but target drug levels will remain constant until the 2-week visit No additional laboratory or imaging tests are needed to maximize recruitment
Interventions
Reduced-dose steroids intervention oral prednisone 30mgm2 1mgkg max 40mg daily until remission then 20mgm2 066mgkg max 25mg on alternate days for four weeks
Standard-dose steroids control oral prednisone 60mgm2 2mgkg max 60mg daily until remission then 40mgm2 15mgkg max 50mg on alternate days for four weeks
Randomization 11 using permuted blocks If a participant does not achieve remission by 2-weeks develops symptomatic edema stage 2 acute kidney injury or thromboembolism they will be escalated to standard-dose steroids
Outcomes
The primary outcome is recruitment rate number enrolled per month since it is the greatest anticipated barrier to RCT feasibility Other feasibility tolerability and safety outcomes are listed in Table 1 The pilot study will test case report forms data management quality control and training systems We will estimate treatment effect for the full-scale RCTs primary outcome complete remission without steroid dose escalation by 2-weeks to re-estimate sample size and evaluate full-scale RCT feasibility
Sample size
For this pilot study we will recruit 50 children 25 per arm which is 15 of the estimated sample size of the full-scale RCT Sample size for this pilot must be adequate to assess RCT feasibility
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None