Idiopathic Nephrotic SyndromePhase 4NCT07151456
Short-term gluCOCOrticoid in Adult STEROID-sensitive Nephrotic Syndrome: The COCO-ASTEROID Study
A Phase 4 study testing Conventional 24-week glucocorticoid regimen and short-term course (12 week) glucocorticoid regimen in people with Idiopathic Nephrotic Syndrome, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
This study will compare a short-term course (12 week) glucocorticoid regimen with the Conventional 24-week regimen as originally proposed by KDIGO. The purpose of the study is to determine a short-term course (12 week) of glucocorticoid decreases the time to first relapse in adults presenting with steroid sensitive… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Idiopathic Nephrotic Syndrome
- What is being tested?
- Conventional 24-week glucocorticoid regimen and short-term course (12 week) glucocorticoid regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Urine protein: creatinine ratio ≥3000mg/g (300mg/mmol)
- Serum/plasma albumin level < 30g/L
- Age ≥ 16 years at the time of diagnosis
- No prior therapy with steroids, immunosuppressive or cytotoxic agents for any form of renal disease (other than the 28 days of prednisolone therapy given initially as routine clinical practice)
- No evidence of underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome
- Informed consent
- SSNS defined as Complete remission within 4 weeks of prednisone or prednisolone at standard dose
Who cannot join
- Secondary nephrotic syndrome
- Contradictions for glucocorticoids
- SRNS: Lack of complete remission within 4 weeks of therapy with daily prednisone or prednisolone at standard dose
- anti-PLA2R positive
- Adults with histological changes other than minimal lesion or focal segmental glomerular sclerosis (FSGS) glomerulonephritis where renal biopsy has been undertaken
- Adults with a prior history of poor compliance with medical therapy Known allergy to glucocorticoid therapy
- Other situations where the researcher deems it inappropriate to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Tianxin Chen, PhD, +86057755578056, ctxzjf@163.com
About this study
Official title: Short-term vs Conventional Glucocorticoid Therapy for the Treatment of the Initial Episode of Adult Patient With Steroid-sensitive Idiopathic Nephrotic Syndrome
This study will compare a short-term course (12 week) glucocorticoid regimen with the Conventional 24-week regimen as originally proposed by KDIGO. The purpose of the study is to determine a short-term course (12 week) of glucocorticoid decreases the time to first relapse in adults presenting with steroid sensitive nephrotic syndrome.
- Conditions
- Idiopathic Nephrotic Syndrome
- Being tested
- Conventional 24-week glucocorticoid regimen, short-term course (12 week) glucocorticoid regimen
- Medical subject headings
- Nephrosis, Lipoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional 24-week glucocorticoid regimenDrug
Weeks 1 - 4, Prednisolone 1mg/kg/day (max 80mg); Weeks 5 - 6: Prednisolone 0.8mg/kg/day (max 60mg); Weeks 7 - 8: Prednisolone 0.6mg/kg/day (max 50mg); Weeks 9 - 10: Prednisolone 0.5mg/kg/day (max 40mg); Weeks 11 - 12: Prednisolone 0.4mg/kg/day (max 30mg); Weeks 13 - 16: Prednisolone 0.3mg/kg/day (max 25mg); Weeks 17 - 20: Prednisolone 0.2mg/kg/day (max 15 Weeks 21 - 24: Prednisolone 0.1mg/kg/day (max 10mg).
short-term course (12 week) glucocorticoid regimenDrug
Weeks 1 - 4, Prednisolone 1mg/kg/day (max 80mg); Weeks 5-8: Prednisolone 1mg/kg/day (max 80mg) on alternate days; 9-12: Prednisolone 0.5mg/kg/day (max 40mg) on alternate days
| Study group | Role | What they receive |
|---|---|---|
| conventional course prednisolone arm | Active comparator | Not described Receives: Drug: Conventional 24-week glucocorticoid regimen |
| short-term course prednisolone arm | Experimental | Not described Receives: Drug: short-term course (12 week) glucocorticoid regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse
Relapse of proteinuria is defined by Albustix positive proteinuria (+++ or greater) for 3 consecutive days or the presence of generalised oedema plus 3+ proteinuria.
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
Relapse rate
the proportion of adults who develop relapsing
Measured: 12 months，24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Nephrotic SyndromeStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianxin Chen, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151456
- Sponsor's protocol ID
- KY2025-303
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evans JHC, Long E. A national audit of nephrotic syndrome: The initial course of prednisolone and outcome. Abstract. Ped Nephrol 1998;12(7):C154
Hodson EM, Knight JF, Willis NS, Craig JC. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev. 2004;(2):CD001533. doi: 10.1002/14651858.CD001533.pub2.
PubMed 15106158Ksiazek J, Wyszynska T. Short versus long initial prednisone treatment in steroid-sensitive nephrotic syndrome in children. Acta Paediatr. 1995 Aug;84(8):889-93. doi: 10.1111/j.1651-2227.1995.tb13787.x.
PubMed 7488812Bargman JM. Management of minimal lesion glomerulonephritis: evidence-based recommendations. Kidney Int Suppl. 1999 Jun;70:S3-16. doi: 10.1046/j.1523-1755.1999.07002.x.
PubMed 10369190Abramowicz M, Barnett HL, Edelmann CM Jr, Greifer I, Kobayashi O, Arneil GC, Barron BA, Gordillo-P G, Hallman N, Tiddens HA. Controlled trial of azathioprine in children with nephrotic syndrome. A report for the international study of kidney disease in children. Lancet. 1970 May 9;1(7654):959-61. doi: 10.1016/s0140-6736(70)91093-7. No abstract available.
PubMed 4191931Brodehl J. Conventional therapy for idiopathic nephrotic syndrome in children. Clin Nephrol. 1991;35 Suppl 1:S8-15.
PubMed 1860269Consensus statement on management and audit potential for steroid responsive nephrotic syndrome. Report of a Workshop by the British Association for Paediatric Nephrology and Research Unit, Royal College of Physicians. Arch Dis Child. 1994 Feb;70(2):151-7. doi: 10.1136/adc.70.2.151. No abstract available.
PubMed 8129444Trompeter RS, Lloyd BW, Hicks J, White RH, Cameron JS. Long-term outcome for children with minimal-change nephrotic syndrome. Lancet. 1985 Feb 16;1(8425):368-70. doi: 10.1016/s0140-6736(85)91387-x.
PubMed 2857421
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term vs Conventional Glucocorticoid Therapy for the Treatment of the Initial Episode of Adult Patient With Steroid-sensitive Idiopathic Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT07151456
- Acronym / sponsor ID
- KY2025-303
- Conditions
- Idiopathic Nephrotic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 3 Sep 2025 (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 will compare a short-term course (12 week) glucocorticoid regimen with the Conventional 24-week regimen as originally proposed by KDIGO. The purpose of the study is to determine a short-term course (12 week) of glucocorticoid decreases the time to first relapse in adults presenting with steroid sensitive nephrotic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional course prednisolone arm | Active comparator | Drug: Conventional 24-week glucocorticoid regimen |
| short-term course prednisolone arm | Experimental | Drug: short-term course (12 week) glucocorticoid regimen |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Urine protein: creatinine ratio ≥3000mg/g (300mg/mmol)
- Serum/plasma albumin level < 30g/L
- Age ≥ 16 years at the time of diagnosis
- No prior therapy with steroids, immunosuppressive or cytotoxic agents for any form of renal disease (other than the 28 days of prednisolone therapy given initially as routine clinical practice)
- No evidence of underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome
Key exclusion criteria (7 listed)
- Secondary nephrotic syndrome
- Contradictions for glucocorticoids
- SRNS: Lack of complete remission within 4 weeks of therapy with daily prednisone or prednisolone at standard dose
- anti-PLA2R positive
- Adults with histological changes other than minimal lesion or focal segmental glomerular sclerosis (FSGS) glomerulonephritis where renal biopsy has been undertaken
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 |
|---|---|---|
| Conventional 24-week glucocorticoid regimenWeeks 1 - 4, Prednisolone 1mg/kg/day (max 80mg); Weeks 5 - 6: Prednisolone 0.8mg/kg/day (max 60mg); Weeks 7 - 8: Prednisolone 0.6mg/kg/day (max 50mg); Weeks 9 - 10: Prednisolone 0.5mg/kg/day (max 40mg); Weeks 11 - 12: Prednisolone 0.4mg/kg/day (max 30mg); Weeks 13 - 16: Prednisolone 0.3mg/kg/day (max 25mg); Weeks 17 - 20: Prednisolone 0.2mg/kg/day (max 15 Weeks 21 - 24: Prednisolone 0.1mg/kg/day (max 10mg). | Drug | conventional course prednisolone arm |
| short-term course (12 week) glucocorticoid regimenWeeks 1 - 4, Prednisolone 1mg/kg/day (max 80mg); Weeks 5-8: Prednisolone 1mg/kg/day (max 80mg) on alternate days; 9-12: Prednisolone 0.5mg/kg/day (max 40mg) on alternate days | Drug | short-term course prednisolone arm |
Primary outcome
Relapse
Time frame: through study completion, an average of 2 years
Relapse of proteinuria is defined by Albustix positive proteinuria (+++ or greater) for 3 consecutive days or the presence of generalised oedema plus 3+ proteinuria.
1 secondary outcome
Relapse rate
Time frame: 12 months，24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- BackgroundEvans JHC, Long E. A national audit of nephrotic syndrome: The initial course of prednisolone and outcome. Abstract. Ped Nephrol 1998;12(7):C154
- Background: PubMed 15106158Hodson EM, Knight JF, Willis NS, Craig JC. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev. 2004;(2):CD001533. doi: 10.1002/14651858.CD001533.pub2.
- Background: PubMed 7488812Ksiazek J, Wyszynska T. Short versus long initial prednisone treatment in steroid-sensitive nephrotic syndrome in children. Acta Paediatr. 1995 Aug;84(8):889-93. doi: 10.1111/j.1651-2227.1995.tb13787.x.
- Background: PubMed 10369190Bargman JM. Management of minimal lesion glomerulonephritis: evidence-based recommendations. Kidney Int Suppl. 1999 Jun;70:S3-16. doi: 10.1046/j.1523-1755.1999.07002.x.
- Background: PubMed 4191931Abramowicz M, Barnett HL, Edelmann CM Jr, Greifer I, Kobayashi O, Arneil GC, Barron BA, Gordillo-P G, Hallman N, Tiddens HA. Controlled trial of azathioprine in children with nephrotic syndrome. A report for the international study of kidney disease in children. Lancet. 1970 May 9;1(7654):959-61. doi: 10.1016/s0140-6736(70)91093-7. No abstract available.
- Background: PubMed 1860269Brodehl J. Conventional therapy for idiopathic nephrotic syndrome in children. Clin Nephrol. 1991;35 Suppl 1:S8-15.
- Background: PubMed 8129444Consensus statement on management and audit potential for steroid responsive nephrotic syndrome. Report of a Workshop by the British Association for Paediatric Nephrology and Research Unit, Royal College of Physicians. Arch Dis Child. 1994 Feb;70(2):151-7. doi: 10.1136/adc.70.2.151. No abstract available.
- Background: PubMed 2857421Trompeter RS, Lloyd BW, Hicks J, White RH, Cameron JS. Long-term outcome for children with minimal-change nephrotic syndrome. Lancet. 1985 Feb 16;1(8425):368-70. doi: 10.1016/s0140-6736(85)91387-x.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Nephrotic Syndrome
RecruitingPhase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
Nephrotic Syndrome, Proteinuria
Active, not recruitingPhase 3
Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy With Nephrotic Syndrome
Glomerulonephritis, Membranous, Nephrotic Syndrome，Idiopathic
Not yet recruiting
Comparison of Efficacy and Safety of Albumin Versus Fresh Frozen Plasma in Managing Diuretic Resistant Edema in Children With Idiopathic Nephrotic Syndrome.
Idiopathic Nephrotic Syndrome (INS)
Not yet recruitingEarly Phase 1
RD06-05 Universal CD19/BCMA CAR-T for Refractory Pediatric Autoimmune Diseases
Autoimmune Diseases, SLE - Systemic Lupus Erythematosus
RecruitingPhase 2
Atacicept in Multiple Glomerular Diseases
pMN, IgAN
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.
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conventional 24-week glucocorticoid regimen and short-term course (12 week) glucocorticoid regimen in people with Idiopathic Nephrotic Syndrome, run by First Affiliated Hospital of Wenzhou Medical University at 1 site 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 7 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: opening soon, as of the sponsor's last update on 3 Sep 2025. 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07151456, which also lists 8 linked publications.
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 3 Sep 2025.