Nephrotic Syndrome in ChildrenPhase 3NCT06079788
Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial.
A Phase 3 study testing Adrenocorticotrophic Hormone and Steroid in people with Nephrotic Syndrome in Children, run by Mao Jianhua at 8 sites in China.
Trial summary
Primary nephrotic syndrome accounts for approximately 90% of the total number of nephrotic syndrome in childhood and it is the most common glomerular disease in children. Although treatment with steroids is useful for primary nephrotic syndrome, proving to cause frequent relapse/steroid-dependent nephrotic syndrome… Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Nephrotic Syndrome in Children
- What is being tested?
- Adrenocorticotrophic Hormone and Steroid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 8 sitesChina
- Study dates
- 1 Nov 2023to 31 Dec 2026
- Phase
- Phase 3
- 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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2-14 years old;
- Sensitive but frequent relapses or steroids dependence nephrotic syndrome
- No severe hormonal side effects and/or low-dose steroids dependent idiopathic nephrotic syndrome in children (defined as two relapses with an average dose < 0.5mg/kg/day or equivalent alternate-day dose)
- Normal renal function: eGFR≥90ml/min/1.73m2;
- Morning urine protein <1+ or urine protein-creatinine ratio <0.2g/g (<20 mg/mmol) for 3 consecutive days and above when in enroll;
- Prednisone dose was 1.5-2 mg/kg per day before admission;
- No use of other immunosuppressants (such as tacrolimus, mortecophenolate, cyclosporin A, cyclophosphamide, levamisole, imidazole ribin, or tripterygium, etc.) within 3 months, and no use of rituximab or beliumab within 6 months.
Who cannot join
- Family history of nephrotic syndrome, chronic glomerulonephritis, uremia and other kidney diseases;
- Patients with congenital or acquired immunodeficiency, or with active tuberculosis, active CMV, EBV, hepatitis B, hepatitis C, HIV infection, deep fungal infection, or other active infections;
- Recurrent or persistent hypertension;
- Secondary nephrotic syndrome, such as nephrotic syndrome secondary to systemic lupus erythematosus, diabetes, drug poisoning and infection;
- Combined with other kidney diseases, such as polycystic kidney, ANCA vasculitis, urinary system malformations, etc.;
- Patients with hypertension, diabetes, tuberculosis, suppurative or fungal infection, gastric and duodenal ulcer disease and heart failure; Patients with other serious heart, liver and other important organs, blood system, endocrine system and other system lesions;
Show all 13Show fewer
- Co-occurrence of other monogenic genetic diseases known to affect the condition of nephrotic syndrome;
- Patients with serious autoimmune diseases or tumors;
- Use of other immunosuppressants (such as tacrolimus, mortecophenolate, cyclosporin A, cyclophosphamide, levamisole, imidazole ribin, or tripterygium, etc.) within 3 months, and no use of rituximab or beliumab within 6 months;
- Patients who are known to be allergic to ACTH, glucocorticoids, or any of the components of these drugs, and patients with severe hormone-related side effects
- History of organ transplantation (excluding corneal and hair transplantation);
- Patients who had participated in other clinical trials within three months prior to enrollment;
- Any patient whom the investigator determines is not suitable for inclusion in the trial.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
yi Xie contact
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Children's Hospital affiliated to Capital Institute of Pediatrics
Beijing, 100000
chaoying chen, MD
- Recruiting
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Mao Jianhua, MD, 13616819071, maojh88@zju.edu.cn
- Recruiting
Kunming Children's Hospital
Kunming, Yunnan, 650000
bo Zhao, MD
- Recruiting
Nanjing Children's Hospital
Nanjing, Jiangsu, 210008
Fei Zhao, MD
Fei Zhao, MD
- Recruiting
Ningbo Women & Children's Hospital
Ningbo, Zhejiang, 315000
huaqiao Qiao, MD
- Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200000
guimei Guo, MD
- Recruiting
Yuying Childrens Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
xuan de Wang, MD
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Jianhua Zhou, MD
Jianhua Zhou, MD
About this study
Primary nephrotic syndrome accounts for approximately 90% of the total number of nephrotic syndrome in childhood and it is the most common glomerular disease in children. Although treatment with steroids is useful for primary nephrotic syndrome, proving to cause frequent relapse/steroid-dependent nephrotic syndrome after treatment and the usage of immunosuppressive agents has become a new choice for the treatment of such patients. This study is a prospective, multicenter, randomized，open-label clinical trial, evaluating the efficacy and safety of steroid combined with adrenocorticotrophic hormone（ACTH） to children who with frequently relapsing or steroid-dependent nephrotic syndrome, all we wish to obtain the proper drug choice and individualized treatment options for children with nephrotic syndrome.
Read the detailed description
Although steroids are recognized as first-line treatments for nephrotic syndrome, the vast majority of children relapse, and about half of them have frequent relapse or steroids dependence after treatment with steroids alone. Some children experienced steroids-resistance after multiple relapses, and eventually developed into chronic kidney dysfunction. Long-term or repeated application of large doses of steroids will lead to side effects such as obesity, growth retardation, and hypertension. Although the treatment of steroids with immunosuppressive agents is a new choice for the treatment of such patients, traditional immunosuppressive agents will bring some serious irreversible side effects.
The clinical application of ACTH in children with nephrotic syndrome dates back to the late 1940s. In recent years, the new mechanism of action of ACTH is also being explored. A number of clinical studies on the treatment of nephrotic syndrome by ACTH have found that it can still achieve good efficacy in patients who are ineffective in first-line treatment. This study evaluated the efficacy of ACTH in the treatment of relapsing or steroid-dependent nephrotic syndrome in children, in order to provide a more effective and safer treatment for children with nephrotic syndrome as well as the therapeutic medication options.
- Conditions
- Nephrotic Syndrome in Children
- Being tested
- Adrenocorticotrophic Hormone, Steroid
- Keywords
- Nephrotic Syndrome, Frequently Relapsing Nephrotic Syndrome, Steroid Dependent Nephrotic Syndrome, Adrenocorticotropic Hormone
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adrenocorticotrophic HormoneDrug
Also called ACTH
For patients in complete remission, ACTH is given at a prednisone dose of 1.5-2mg/kg qod or 0.75-1mg/kg qd. ACTH 2 IU/kg/ day, qd,（the maximum dose ≤ 50 IU）, 28 days of continuous use for 5 days， for 24 weeks.
Prednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd, then gradually taper the steroid by 0.25mg/kg qod or 0.125mg/kg qd every 4 weeks.If stable, taper to 5mg qod (body surface area > 1.0m2) and 2.5mg qod (body surface area < 1.0m2) and maintain the dose until study completion.
SteroidDrug
For patients in complete remission, Prednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd, then gradually taper the steroid by 0.25mg/kg qod or 0.125mg/kg qd every 4 weeks. If stable, taper to 5mg qod (body surface area > 1.0m2) and 2.5mg qod (body surface area < 1.0m2) and maintain the dose until study completion.
| Study group | Role | What they receive |
|---|---|---|
| Adrenocorticotrophic Hormone Group | Experimental | ACTH 2 IU/kg/ day, qd,（the maximum dose ≤ 50 IU）, 28 days of continuous use for 5 days， for 24 weeks.
Prednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd Receives: Drug: Adrenocorticotrophic Hormone |
| Steroid Group | Active comparator | Prednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd, then gradually taper the steroid by 0.25mg/kg （qod） or 0.125mg/kg （qd） every 4 weeks. Receives: Drug: Steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival time(day) within 48 weeks
Recurrence-free survival time(day) within 48 weeks
Measured: Within 48 weeks after randomization
Secondary outcomes (8)
Number of relapses during 48 weeks follow up
Number of nephrotic syndrome relapses per patient year during the 48 weeks after randomization
Measured: Within 48 weeks after randomization
The first time to relapse
The first time to relapse after patients taking part in this study
Measured: Within 48 weeks after randomization
Cumulative prednisone dosage (milligrams per kilogram per year)
The total dosage of prednisones from the beginning to the end of the trial
Measured: Within 48 weeks after randomization
Change in renal function of the patients
The change for renal function was judged by the changes of serum creatinine and estimated glomerular filtration rate in each follow-up during the study
Measured: Within 48 weeks after randomization
Change in anthropometry and growth velocity during 48 weeks after randomization
Changes in standard deviation scores for weight, height and body mass index during 48 weeks after randomization
Measured: Within 48 weeks after randomization
Change in serum cholesterol, hemoglobin and blood albumin of the patients
The changes of serum cholesterol, hemoglobin and blood albumin in each follow-up during the study
Measured: Within 48 weeks after randomization
Incidence of infection
The incidence of infection during the study
Measured: Within 48 weeks after randomization
Adverse event
The number of harmful reactions and the types of adverse events during the study
Measured: Within 48 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (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 Nephrotic Syndrome in ChildrenStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mao Jianhua
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital, Children's Hospital affiliated to Capital Institute of Pediatrics, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Children's Hospital of Nanjing Medical University, Kunming Children's Hospital, Yuying Children's Hospital of Wenzhou Medical University, Ningbo Women & Children's Hospital
- Responsible party
- Sponsor-investigator, Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine
- Investigators
- yi Xie, Study director, Recruiting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079788
- Sponsor's protocol ID
- STAIR
- Status last verified
- Oct 2023
- First submitted
- 8 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang CS, Greenbaum LA. Nephrotic Syndrome. Pediatr Clin North Am. 2019 Feb;66(1):73-85. doi: 10.1016/j.pcl.2018.08.006.
PubMed 30454752Wong W. Idiopathic nephrotic syndrome in New Zealand children, demographic, clinical features, initial management and outcome after twelve-month follow-up: results of a three-year national surveillance study. J Paediatr Child Health. 2007 May;43(5):337-41. doi: 10.1111/j.1440-1754.2007.01077.x.
PubMed 17489822Chakraborty R, Mehta A, Nair N, Nemer L, Jain R, Joshi H, Raina R. ACTH Treatment for Management of Nephrotic Syndrome: A Systematic Review and Reappraisal. Int J Nephrol. 2020 Jun 4;2020:2597079. doi: 10.1155/2020/2597079. eCollection 2020.
PubMed 32566293Lieberman KV, Pavlova-Wolf A. Adrenocorticotropic hormone therapy for the treatment of idiopathic nephrotic syndrome in children and young adults: a systematic review of early clinical studies with contemporary relevance. J Nephrol. 2017 Feb;30(1):35-44. doi: 10.1007/s40620-016-0308-3. Epub 2016 Apr 16.
PubMed 27084801Hladunewich MA, Cattran D, Beck LH, Odutayo A, Sethi S, Ayalon R, Leung N, Reich H, Fervenza FC. A pilot study to determine the dose and effectiveness of adrenocorticotrophic hormone (H.P. Acthar(R) Gel) in nephrotic syndrome due to idiopathic membranous nephropathy. Nephrol Dial Transplant. 2014 Aug;29(8):1570-7. doi: 10.1093/ndt/gfu069. Epub 2014 Apr 8.
PubMed 24714414Hogan J, Bomback AS, Mehta K, Canetta PA, Rao MK, Appel GB, Radhakrishnan J, Lafayette RA. Treatment of idiopathic FSGS with adrenocorticotropic hormone gel. Clin J Am Soc Nephrol. 2013 Dec;8(12):2072-81. doi: 10.2215/CJN.02840313. Epub 2013 Sep 5.
PubMed 24009220Zand L, Canetta P, Lafayette R, Aslam N, Jan N, Sethi S, Fervenza FC. An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of Progression. Kidney Int Rep. 2019 Oct 31;5(1):58-65. doi: 10.1016/j.ekir.2019.10.007. eCollection 2020 Jan.
PubMed 31922061Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.
PubMed 39513526
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial.
- ClinicalTrials.gov ID
- NCT06079788
- Acronym / sponsor ID
- STAIR
- Conditions
- Nephrotic Syndrome in Children
- Keywords
- Nephrotic Syndrome, Frequently Relapsing Nephrotic Syndrome, Steroid Dependent Nephrotic Syndrome, Adrenocorticotropic Hormone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Mao JianhuaUniversity, hospital or other
- Collaborators
- Tongji Hospital, Children's Hospital affiliated to Capital Institute of Pediatrics, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Children's Hospital of Nanjing Medical University, Kunming Children's Hospital, Yuying Children's Hospital of Wenzhou Medical University, Ningbo Women & Children's Hospital
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Oct 2023 (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.
Primary nephrotic syndrome accounts for approximately 90% of the total number of nephrotic syndrome in childhood and it is the most common glomerular disease in children. Although treatment with steroids is useful for primary nephrotic syndrome, proving to cause frequent relapse/steroid-dependent nephrotic syndrome after treatment and the usage of immunosuppressive agents has become a new choice for the treatment of such patients. This study is a prospective, multicenter, randomized，open-label clinical trial, evaluating the efficacy and safety of steroid combined with adrenocorticotrophic hormone（ACTH） to children who with frequently relapsing or steroid-dependent nephrotic syndrome, all we wish to obtain the proper drug choice and individualized treatment options for children with nephrotic syndrome.
Detailed description
Although steroids are recognized as first-line treatments for nephrotic syndrome, the vast majority of children relapse, and about half of them have frequent relapse or steroids dependence after treatment with steroids alone. Some children experienced steroids-resistance after multiple relapses, and eventually developed into chronic kidney dysfunction. Long-term or repeated application of large doses of steroids will lead to side effects such as obesity, growth retardation, and hypertension. Although the treatment of steroids with immunosuppressive agents is a new choice for the treatment of such patients, traditional immunosuppressive agents will bring some serious irreversible side effects.
The clinical application of ACTH in children with nephrotic syndrome dates back to the late 1940s. In recent years, the new mechanism of action of ACTH is also being explored. A number of clinical studies on the treatment of nephrotic syndrome by ACTH have found that it can still achieve good efficacy in patients who are ineffective in first-line treatment. This study evaluated the efficacy of ACTH in the treatment of relapsing or steroid-dependent nephrotic syndrome in children, in order to provide a more effective and safer treatment for children with nephrotic syndrome as well as the therapeutic medication options.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adrenocorticotrophic Hormone Group | Experimental | Drug: Adrenocorticotrophic HormoneACTH 2 IU/kg/ day, qd,（the maximum dose ≤ 50 IU）, 28 days of continuous use for 5 days， for 24 weeks. Prednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd |
| Steroid Group | Active comparator | Drug: SteroidPrednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd, then gradually taper the steroid by 0.25mg/kg （qod） or 0.125mg/kg （qd） every 4 weeks. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 2-14 years old;
- Sensitive but frequent relapses or steroids dependence nephrotic syndrome
- No severe hormonal side effects and/or low-dose steroids dependent idiopathic nephrotic syndrome in children (defined as two relapses with an average dose < 0.5mg/kg/day or equivalent alternate-day dose)
- Normal renal function: eGFR≥90ml/min/1.73m2;
- Morning urine protein <1+ or urine protein-creatinine ratio <0.2g/g (<20 mg/mmol) for 3 consecutive days and above when in enroll;
Key exclusion criteria (13 listed)
- Family history of nephrotic syndrome, chronic glomerulonephritis, uremia and other kidney diseases;
- Patients with congenital or acquired immunodeficiency, or with active tuberculosis, active CMV, EBV, hepatitis B, hepatitis C, HIV infection, deep fungal infection, or other active infections;
- Recurrent or persistent hypertension;
- Secondary nephrotic syndrome, such as nephrotic syndrome secondary to systemic lupus erythematosus, diabetes, drug poisoning and infection;
- Combined with other kidney diseases, such as polycystic kidney, ANCA vasculitis, urinary system malformations, etc.;
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 |
|---|---|---|
| Adrenocorticotrophic HormoneAlso: ACTHFor patients in complete remission, ACTH is given at a prednisone dose of 1.5-2mg/kg qod or 0.75-1mg/kg qd. ACTH 2 IU/kg/ day, qd,（the maximum dose ≤ 50 IU）, 28 days of continuous use for 5 days， for 24 weeks. Prednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd, then gradually taper the steroid by 0.25mg/kg qod or 0.125mg/kg qd every 4 weeks.If stable, taper to 5mg qod (body surface area > 1.0m2) and 2.5mg qod (body surface area < 1.0m2) and maintain the dose until study completion. | Drug | Adrenocorticotrophic Hormone Group |
| SteroidFor patients in complete remission, Prednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd, then gradually taper the steroid by 0.25mg/kg qod or 0.125mg/kg qd every 4 weeks. If stable, taper to 5mg qod (body surface area > 1.0m2) and 2.5mg qod (body surface area < 1.0m2) and maintain the dose until study completion. | Drug | Steroid Group |
Primary outcome
Recurrence-free survival time(day) within 48 weeks
Time frame: Within 48 weeks after randomization
Recurrence-free survival time(day) within 48 weeks
8 secondary outcomes
Number of relapses during 48 weeks follow up
Time frame: Within 48 weeks after randomization
The first time to relapse
Time frame: Within 48 weeks after randomization
Cumulative prednisone dosage (milligrams per kilogram per year)
Time frame: Within 48 weeks after randomization
Change in renal function of the patients
Time frame: Within 48 weeks after randomization
Change in anthropometry and growth velocity during 48 weeks after randomization
Time frame: Within 48 weeks after randomization
Change in serum cholesterol, hemoglobin and blood albumin of the patients
Time frame: Within 48 weeks after randomization
Incidence of infection
Time frame: Within 48 weeks after randomization
Adverse event
Time frame: Within 48 weeks after randomization
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 12 Oct 2023.
- Background: PubMed 30454752Wang CS, Greenbaum LA. Nephrotic Syndrome. Pediatr Clin North Am. 2019 Feb;66(1):73-85. doi: 10.1016/j.pcl.2018.08.006.
- Background: PubMed 17489822Wong W. Idiopathic nephrotic syndrome in New Zealand children, demographic, clinical features, initial management and outcome after twelve-month follow-up: results of a three-year national surveillance study. J Paediatr Child Health. 2007 May;43(5):337-41. doi: 10.1111/j.1440-1754.2007.01077.x.
- Background: PubMed 32566293Chakraborty R, Mehta A, Nair N, Nemer L, Jain R, Joshi H, Raina R. ACTH Treatment for Management of Nephrotic Syndrome: A Systematic Review and Reappraisal. Int J Nephrol. 2020 Jun 4;2020:2597079. doi: 10.1155/2020/2597079. eCollection 2020.
- Background: PubMed 27084801Lieberman KV, Pavlova-Wolf A. Adrenocorticotropic hormone therapy for the treatment of idiopathic nephrotic syndrome in children and young adults: a systematic review of early clinical studies with contemporary relevance. J Nephrol. 2017 Feb;30(1):35-44. doi: 10.1007/s40620-016-0308-3. Epub 2016 Apr 16.
- Background: PubMed 24714414Hladunewich MA, Cattran D, Beck LH, Odutayo A, Sethi S, Ayalon R, Leung N, Reich H, Fervenza FC. A pilot study to determine the dose and effectiveness of adrenocorticotrophic hormone (H.P. Acthar(R) Gel) in nephrotic syndrome due to idiopathic membranous nephropathy. Nephrol Dial Transplant. 2014 Aug;29(8):1570-7. doi: 10.1093/ndt/gfu069. Epub 2014 Apr 8.
- Background: PubMed 24009220Hogan J, Bomback AS, Mehta K, Canetta PA, Rao MK, Appel GB, Radhakrishnan J, Lafayette RA. Treatment of idiopathic FSGS with adrenocorticotropic hormone gel. Clin J Am Soc Nephrol. 2013 Dec;8(12):2072-81. doi: 10.2215/CJN.02840313. Epub 2013 Sep 5.
- Background: PubMed 31922061Zand L, Canetta P, Lafayette R, Aslam N, Jan N, Sethi S, Fervenza FC. An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of Progression. Kidney Int Rep. 2019 Oct 31;5(1):58-65. doi: 10.1016/j.ekir.2019.10.007. eCollection 2020 Jan.
- Derived from this study: PubMed 39513526Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.
- Individual participant dataSharing planned: No
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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.
yi Xie contact
yi Xie study director
Recruiting
8 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 Adrenocorticotrophic Hormone and Steroid in people with Nephrotic Syndrome in Children, run by Mao Jianhua at 8 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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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?
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?
Contact jianhua Mao, MD (0571-87061007, maojh88@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival time(day) within 48 weeks (time frame: Within 48 weeks after randomization). 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 NCT06079788, 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 12 Oct 2023.