A Phase 3 interventional study of Adrenocorticotrophic Hormone and Steroid in Nephrotic Syndrome in Children, sponsored by Mao Jianhua. Recruiting at 8 sites in China. Open to participants aged 2 Years to 14 Years. Per ClinicalTrials.gov, last updated 2023-10-12.
Sponsored by Mao Jianhua · Phase 3, Interventional, and Treatment
Among 34 studies in Nephrotic Syndrome with a site in China — 19 open to participants now, 21 under way, 5 of them phase 3. Nephrotic Syndrome · China.
Among the 34 studies in Nephrotic Syndrome with a site in China, this one is the 4th largest by planned enrollment of the 25 interventional ones, is one of 6 that started in 2023, is one of 10 in phase 3, reaches primary completion later than 4 of the 20 other live ones, and was the 20th registered.
191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.
This study's planned enrollment of 140 is above the median of 46 across 122 interventional studies indexed under Nephrotic Syndrome.
Browse Nephrotic Syndrome studies →19 of the 34 studies in Nephrotic Syndrome with a site in China are open now, in 1 country. Each count lists the studies.
Of the 50 Nephrotic Syndrome studies recruiting now, 23 (46%) set no upper age limit and 22 (44%) stop at 75 or younger; 37 take children under 18; 4 take healthy volunteers.
This study: 2 Years to 14 Years · all sexes · no healthy volunteers.
The full table on the hub →34 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 6 started in 2023.
Median enrollment 36 across the 25 interventional studies, 300 across the 9 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
3 of 34 have an industry lead sponsor. The 10 most frequent:
Mao Jianhua is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Mao Jianhua has 2 studies filed under Nephrotic Syndrome — fewer than ten, so there is no comparison to draw.
2 of the studies in Nephrotic Syndrome with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07612592Children's Hospital of Chongqing Medical UniversityThe Clinical Application Study of Obinutuzumab in Pediatric Refractory Nephrotic Syndrome | 2026-12-01 |
| NCT06161701Zhejiang Provincial People's HospitalSteroid Diabetes in Patients With Kidney Disease | 2026-12-31 |
Among the 34 studies in Nephrotic Syndrome with a site in China, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Adrenocorticotrophic Hormone
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.
Drug: Steroid
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.
Also known as: ACTH
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.
Recurrence-free survival time(day) within 48 weeks
Recurrence-free survival time(day) within 48 weeks
Time frame: Within 48 weeks after randomization
Number of relapses during 48 weeks follow up
Number of nephrotic syndrome relapses per patient year during the 48 weeks after randomization
Time frame: Within 48 weeks after randomization
The first time to relapse
The first time to relapse after patients taking part in this study
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Within 48 weeks after randomization
Incidence of infection
The incidence of infection during the study
Time frame: Within 48 weeks after randomization
Adverse event
The number of harmful reactions and the types of adverse events during the study
Time frame: Within 48 weeks after randomization
Plan to share: No
Start is estimated for Nov 2023; primary completion for Jun 2026, 31 months later.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Adrenocorticotropic Hormone
Mao Jianhua