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New treatment option for Nephrotic Syndrome in Children
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
What this study is testing
What is Adrenocorticotrophic Hormone?
Adrenocorticotrophic Hormone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for nephrotic syndrome in children.
Also referred to as ACTH.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 14
You may be able to join if
- 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...
- 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;
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
- Nanjing, Jiangsu, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
- Wenzhou, Zhejiang, China
- Beijing, China
- Shanghai, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 14 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China; Nanjing, Jiangsu, China; Kunming, Yunnan, China; Hangzhou, Zhejiang, China; Ningbo, Zhejiang, China; Wenzhou, Zhejiang, China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.