Steroid-Sensitive Nephrotic SyndromePhase 3NCT04536181
Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome
A Phase 3 study testing Prednisolone in people with Steroid-Sensitive Nephrotic Syndrome, run by Children's Hospital of Fudan University at 4 sites in China.
Trial summary
This study is a multicentric, prospective, randomized, double blind, placebo controlled trial compared the efficacy of 6 months vs. 3 months of initial prednisolone therapy in decreasing the incidence of FRNS with steroid-sensitive nephrotic syndrome in children age 1 year up to 6 years. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Steroid-Sensitive Nephrotic Syndrome
- What is being tested?
- Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jan 2021to 1 Oct 2022
- Phase
- Phase 3
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Idiopathic, steroid-sensitive, first episode of nephrotic syndrome
- Age 12 months up to 6 years
- Written informed consent
Who cannot join
- Nephrotic syndrome known to be secondary to a systemic disorder, e.g., Immunoglobulin A (IgA) nephropathy, systemic lupus erythematosus, Henoch Schonlein purpura, vasculitis, , hepatitis B or Alport syndrome.
- Therapy with prednisolone for prior episodes of nephrotic syndrome
- Persistent estimated glomerular filtration rate (GFR) <75 ml/min/1.73 m2
- Patients who show relapse during the first 3 months of pre-randomization corticosteroid therapy for nephrotic syndrome
- Patients with initial steroid resistance
- Patients who are allergic to glucocorticoids
- The compliance of patients or their guardians is poor
Trial locations and contacts
4 sites in 1 country.
China4 sites
Children's hospital of Fudan university
Shanghai, Shanghai Municipality, 200000
Shanghai Children's Hospital
Shanghai
Shanghai Children's Medical Center
Shanghai
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
About this study
Official title: Comparative Study of 3 or 6 Months Initial Steroid Treatment in Children Under 6 Years of Age With Steroid Sensitive Nephrotic Syndrome：a Randomized, Double-blind, Placebo-controlled Study
This study is a multicentric, prospective, randomized, double blind, placebo controlled trial compared the efficacy of 6 months vs. 3 months of initial prednisolone therapy in decreasing the incidence of FRNS with steroid-sensitive nephrotic syndrome in children age 1 year up to 6 years. Three months tapering prednisolone or placebo are administrated follow by open-label 3 months standard prednisolone therapy.The cumulative incidence of FRNS and adverse events for one year were evaluated in the 3-month and 6-month groups.
- Conditions
- Steroid-Sensitive Nephrotic Syndrome
- Being tested
- Prednisolone, Placebo
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Also called prednisone
12 weeks prednisolone treatment
PlaceboDrug
12 weeks simulated tablets
| Study group | Role | What they receive |
|---|---|---|
| 3 months group | Placebo comparator | Subjects will receive 12-weeks of placebo following randomization Receives: Drug: Placebo |
| 6 months group | Experimental | 12 Weeks of Prednisolone Therapy Subjects will add an additional 12 weeks of Prednisolone to follow pre-randomization standard of care prednisolone. Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of frequent relapses of nephrotic syndrome at 12th month after 3 month standard treatment
Proportion of patients with frequent relapses at 12th month after 3 month standard treatment.Frequent relapses nephrotic syndrome was defined as two or more relapses within 6 months after completing initial treatment, or four relapses within any period of 12 months, including relapses during initial treatment.
Measured: 12 month period after 3 month standard treatment
Secondary outcomes (7)
Number of relapses during 12 months follow up after 3 month standard treatment
Number of nephrotic syndrome relapses per patient year during the 12-month period after 3 month standard treatment
Measured: 12 month period after 3 month standard treatment
Time to first relapse (days)
Number of days from randomization to occurrence of first relapse
Measured: 12 month period after 3 month standard treatment
Cumulative prednisolone [or corticosteroid equivalent] received during 12 month period after 3 month standard treatment
Total amount of prednisolone [or corticosteroid equivalent] received, as mg/kg/day or mg/m2/day as intervention and for treatment of relapses, during 12 months follow up after 3 month standard treatment
Measured: 12 month period after 3 month standard treatment
The use of steroid-sparing medications
The proportion of patients in each study arm treated with steroid-sparing strategies or medications.it is a binary varibale (1/0). The variable wolud be sette into "1", if the patients use the steroid-sparing medications such as cyclophosphamide, levamisole, mycophenolate mofetil，rituximab and so on.
Measured: 12 month period after 3 month standard treatment
Adverse events during 12-month period after 3 month standard treatment
Number of adverse events experienced, related or unrelated to corticosteroid use
Measured: 12 month period after 3 month standard treatment
Change in height during 12-month period after 3 month standard treatment
The standard deviation scores (SDS) for height will be measured at 12th month and randomization. Change in height is SDS at 12 month minus that of randomization.
Measured: 12 month period after 3 month standard treatment
Occurrence of steroid-dependent nephrotic syndrome at 12th month after 3 month standard treatment
Proportion of patients with steroid-dependent nephrotic syndrome at 12th month after 3 month standard treatment.Steroid-dependent nephrotic syndrome was defined as steroid-sensitive nephrotic syndrome with 2 or more consecutive relapses during tapering or within 14 days of stopping steroids.
Measured: 12 month period after 3 month standard treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Why it stopped: lack of funding
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.
- More trials run by Children's Hospital of Fudan 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Xu, PhD.MD., Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536181
- Sponsor's protocol ID
- CSICS
- Status last verified
- Dec 2020
- First submitted
- 26 Aug 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of 3 or 6 Months Initial Steroid Treatment in Children Under 6 Years of Age With Steroid Sensitive Nephrotic Syndrome：a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04536181
- Acronym / sponsor ID
- CSICS
- Conditions
- Steroid-Sensitive Nephrotic Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 2 Sep 2020 (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.
This study is a multicentric, prospective, randomized, double blind, placebo controlled trial compared the efficacy of 6 months vs. 3 months of initial prednisolone therapy in decreasing the incidence of FRNS with steroid-sensitive nephrotic syndrome in children age 1 year up to 6 years. Three months tapering prednisolone or placebo are administrated follow by open-label 3 months standard prednisolone therapy.The cumulative incidence of FRNS and adverse events for one year were evaluated in the 3-month and 6-month groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 months group | Placebo comparator | Drug: PlaceboSubjects will receive 12-weeks of placebo following randomization |
| 6 months group | Experimental | Drug: Prednisolone12 Weeks of Prednisolone Therapy Subjects will add an additional 12 weeks of Prednisolone to follow pre-randomization standard of care prednisolone. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Idiopathic, steroid-sensitive, first episode of nephrotic syndrome
- Age 12 months up to 6 years
- Written informed consent
Key exclusion criteria (7 listed)
- Nephrotic syndrome known to be secondary to a systemic disorder, e.g., Immunoglobulin A (IgA) nephropathy, systemic lupus erythematosus, Henoch Schonlein purpura, vasculitis, , hepatitis B or Alport syndrome.
- Therapy with prednisolone for prior episodes of nephrotic syndrome
- Persistent estimated glomerular filtration rate (GFR) <75 ml/min/1.73 m2
- Patients who show relapse during the first 3 months of pre-randomization corticosteroid therapy for nephrotic syndrome
- Patients with initial steroid resistance
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 |
|---|---|---|
| PrednisoloneAlso: prednisone12 weeks prednisolone treatment | Drug | 6 months group |
| Placebo12 weeks simulated tablets | Drug | 3 months group |
Primary outcome
Occurrence of frequent relapses of nephrotic syndrome at 12th month after 3 month standard treatment
Time frame: 12 month period after 3 month standard treatment
Proportion of patients with frequent relapses at 12th month after 3 month standard treatment.Frequent relapses nephrotic syndrome was defined as two or more relapses within 6 months after completing initial treatment, or four relapses within any period of 12 months, including relapses during initial treatment.
7 secondary outcomes
Number of relapses during 12 months follow up after 3 month standard treatment
Time frame: 12 month period after 3 month standard treatment
Time to first relapse (days)
Time frame: 12 month period after 3 month standard treatment
Cumulative prednisolone [or corticosteroid equivalent] received during 12 month period after 3 month standard treatment
Time frame: 12 month period after 3 month standard treatment
The use of steroid-sparing medications
Time frame: 12 month period after 3 month standard treatment
Adverse events during 12-month period after 3 month standard treatment
Time frame: 12 month period after 3 month standard treatment
Change in height during 12-month period after 3 month standard treatment
Time frame: 12 month period after 3 month standard treatment
Occurrence of steroid-dependent nephrotic syndrome at 12th month after 3 month standard treatment
Time frame: 12 month period after 3 month standard treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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Steroid-Dependent Nephrotic Syndrome, Steroid-Sensitive Nephrotic Syndrome
Not yet recruitingPhase 3
Zuberitamab in the First Episode of Paediatric Nephrotic Syndrome
Nephrotic Syndrome
RecruitingPhase 2
Dupilumab Therapy in Nephrotic Syndrome in Children
Nephrotic Syndrome in Children, Nephrotic Syndrome Steroid-Dependent
Not yet recruitingPhase 4
Short-term gluCOCOrticoid in Adult STEROID-sensitive Nephrotic Syndrome: The COCO-ASTEROID Study
Idiopathic Nephrotic Syndrome
Not yet recruitingObservational study
Biomarkers and Outcome Predictors of Pediatric Nephrotic Syndrome: A Genetic, Transcriptomic, and Secretome Multiomics Study
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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.
Hong Xu, PhD.MD. principal investigator
Children's Hospital of Fudan University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prednisolone in people with Steroid-Sensitive Nephrotic Syndrome, run by Children's Hospital of Fudan University at 4 sites in China.
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 7 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: withdrawn, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Occurrence of frequent relapses of nephrotic syndrome at 12th month after 3 month standard treatment (time frame: 12 month period after 3 month standard treatment). 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 17 Dec 2020.