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Trial registered on ANZCTR


Registration number
ACTRN12621001428853
Ethics application status
Approved
Date submitted
9/09/2021
Date registered
21/10/2021
Date last updated
21/10/2021
Date data sharing statement initially provided
21/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Initial Prednisolone Weaning in Nephrotic Syndrome: adrenal suppression and its association with relapse
Scientific title
Initial Prednisolone Weaning and Adrenal Suppression in Childhood Nephrotic Syndrome
Secondary ID [1] 305270 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Idiopathic Nephrotic Syndrome 323565 0
Adrenal gland suppression 323566 0
Condition category
Condition code
Renal and Urogenital 321115 321115 0 0
Kidney disease
Metabolic and Endocrine 321116 321116 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral prednisolone therapy for initial presentation of Childhood Nephrotic Syndrome. Dosing regimen will be followed for this period whether in hospital or at home.

Arm 1- 2 step wean 60mg/m2/day for 4 weeks, then 40mg/m2/alternate day for 4 weeks
Arm 2- control
Intervention code [1] 321672 0
Treatment: Drugs
Comparator / control treatment
Control group is Arm 2 (standard of care in the involved trial hospitals)

- Oral prednisolone multi-step wean 60mg/m2/day for 4 weeks, 40mg/m2/alt daily for 4 weeks, 20mg/m2/alt daily for 10 days, 10mg/m2/alt daily for 10 days, 5mg/m2/alt daily for 10 days
Control group
Active

Outcomes
Primary outcome [1] 328890 0
Frequency of adrenal suppression (measured by short synacthen test at the end of the prednisolone regime) in the whole cohort.
Timepoint [1] 328890 0
One test between 3-7 days after ceasing the intervention.
Secondary outcome [1] 400801 0
Frequency of adrenal suppression (as measured by short synacthen testing) according to treatment arm.
Timepoint [1] 400801 0
One test between 3-7 days after ceasing the intervention.
Secondary outcome [2] 400802 0
Frequency of nephrotic relapse (based on participant follow-up) by 12 months of initial prednisolone course according to adrenal suppression.
Timepoint [2] 400802 0
by 12 months of initial prednisolone course
Secondary outcome [3] 400803 0
Frequency of nephrotic relapse ((based on participant follow-up)) by 12 months of initial prednisolone course according to intervention arm.
Timepoint [3] 400803 0
by 12 months of initial prednisolone course
Secondary outcome [4] 400804 0
Frequency of steroid associated adverse events according to intervention arm. This will be assessed at a participant visit between 3-7 days of ceasing the intervention. Measurements will include assessment of possible adverse events including measurements of body mass (BMI as measured by balance scales (weight) and stadiometer (height)), glucose intolerance (HBA1c blood test), blood pressure, and assessment of cushingoid body habitus. A record review will also include review of any infections requiring hospitalisation.
Timepoint [4] 400804 0
One assessment and test between 3-7 days after ceasing prednisolone
Secondary outcome [5] 400805 0
Frequency of steroid dependent nephrotic syndrome during initial prednisolone wean according to intervention arm. This is assessed by follow-up of the participant's nephrotic syndrome diary, direct participant questioning, and medical record review.
Timepoint [5] 400805 0
Steroid dependent nephrotic syndrome is defined as a nephrotic relapse during the prednisolone course or up to 14 days after ceasing prednisolone. These participants will be in direct contact with their treating doctors who will guide prednisolone therapy at this time. If the participant is still in the process of weaning their dose as per the intervention arm, then their dosing will likely be modified, and they will not complete the intervention as described. These participants will remain in the study but will not have adrenal suppression measured as part of the trial.

The outcome of steroid dependency will be assessed at 3-7 days after anticipated prednisolone cessation by chart review or participant visit, and again at 12 months following prednisolone course. All participants will keep a record of their relapses in a diary for 12 months so that an accurate assessment of relapse timing can be ascertained.
Secondary outcome [6] 400806 0
Frequency of the composite outcome steroid dependent nephrotic syndrome and frequently relapsing nephrotic syndrome at 12 months of initial prednisolone course according to intervention arm. This is assessed by follow-up of the participant's nephrotic syndrome diary, direct participant questioning, and medical record review.
Timepoint [6] 400806 0
by 12 months of initial prednisolone course
Secondary outcome [7] 400807 0
Requirement for non-steroidal therapies according to intervention arm. This is assessed by follow-up of the participant's nephrotic syndrome diary, direct participant quesitoning, and medical record review.
Timepoint [7] 400807 0
at 12 months of initial prednisolone course

Eligibility
Key inclusion criteria
Age 2-<16 years
First episode of idiopathic nephrotic syndrome
Minimum age
2 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Past or current pituitary or adrenal disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be undertaken central computer based randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using a randomisation table created by computer software stratified by age and treatment center
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Probability of outcomes between groups will be analysed by fisher's exact test, and logistic regression.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2021
Actual
Date of last participant enrolment
Anticipated
30/05/2026
Actual
Date of last data collection
Anticipated
30/05/2027
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 309639 0
Hospital
Name [1] 309639 0
Monash Health
Country [1] 309639 0
Australia
Primary sponsor type
Individual
Name
Dr Amelia Le Page
Address
Monash Health.
Children's Nephrology
246 Clayton rd
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 310658 0
None
Name [1] 310658 0
Address [1] 310658 0
Country [1] 310658 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309412 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 309412 0
Ethics committee country [1] 309412 0
Australia
Date submitted for ethics approval [1] 309412 0
16/06/2021
Approval date [1] 309412 0
06/07/2021
Ethics approval number [1] 309412 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114066 0
Dr Amelia Le Page
Address 114066 0
Monash Children's Nephrology
246 Clayton Road Clayton VIC 3168
Country 114066 0
Australia
Phone 114066 0
+61 3 85723855
Fax 114066 0
Email 114066 0
Amelia.LePage@monashhealth.org
Contact person for public queries
Name 114067 0
Amelia Le Page
Address 114067 0
Monash Children's Nephrology
246 Clayton Road Clayton VIC 3168
Country 114067 0
Australia
Phone 114067 0
+61 3 85723855
Fax 114067 0
Email 114067 0
Amelia.LePage@monashhealth.org
Contact person for scientific queries
Name 114068 0
Amelia Le Page
Address 114068 0
Monash Children's Nephrology
246 Clayton Road Clayton VIC 3168
Country 114068 0
Australia
Phone 114068 0
+61 3 85723855
Fax 114068 0
Email 114068 0
Amelia.LePage@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.