Henoch Schönlein Purpura NephritisPhase 4FICHSPNNCT07315191
Finerenone Therapy for Pediatric HSPN With Mild Proteinuria
A Phase 4 study testing ACEI / ARB+finerenone and ACEI/ARB in people with Henoch Schönlein Purpura Nephritis, run by Capital Institute of Pediatrics, China at 1 site in China.
Trial summary
Henoch-Schönlein purpura nephritis (HSPN) is the most common secondary glomerular disease in children. About 40% of HSPN cases are accompanied by mild proteinuria, and some of them progress to end-stage renal disease. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Henoch Schönlein Purpura Nephritis
- What is being tested?
- ACEI / ARB+finerenone and ACEI/ARB
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2025to 30 Apr 2028
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children of HSPN meet the following conditions① Age > 3 years old and < 18 years old;
- 24-hour urine protein quantification >= 8mg/h/M2 body surface area (or >= 300mg/d), and < 20mg/h/M2 body surface area (< 1000mg/d);
- 3: 3. Sign the informed consent form.
Who cannot join
- Abnormal renal function: eGFR < 90 ml/min/1.73m^2 body surface area;
- Renal pathological grade >= IV;
- Application of glucocorticoids and/or immunosuppressants within 2 weeks;
- Recent applications involving high-dose glucocorticoids administered for a duration exceeding two weeks.;
- Liver transaminase > 2 times the upper limit of normal;
- Severe cardiac insufficiency;
- Simultaneous use of CYPA4 inhibitors;-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Juan Tu contact
China1 site, 1 recruiting
- Recruiting
Capital Center for Children's Health,Capital Medical University
Beijing, Beijing Municipality, 100020
Haiyun Geng, 86+13681078655, hygjing@126.com
About this study
Official title: The Randomized Controlled Trial of Finerenone Therapy for Pediatric Hennoch Scholein Nephritis With Mild Proteinuria
Henoch-Schönlein purpura nephritis (HSPN) is the most common secondary glomerular disease in children. About 40% of HSPN cases are accompanied by mild proteinuria, and some of them progress to end-stage renal disease. Currently, the treatment for children with mild proteinuria HSPN mainly involves ACEI/ARB, but long-term use of these drugs can lead to an increase in aldosterone levels, affecting therapeutic efficacy. Finerenone can improve vascular endothelial cell dysfunction and renal tissue inflammation and fibrosis, and reduce urinary protein in patients with glomerular diseases. This study intends to conduct an exploratory randomized controlled clinical trial of finerenone in children with HSPN accompanied by a small amount of proteinuria to evaluate the efficacy and safety of finerenone treatment.
- Conditions
- Henoch Schönlein Purpura Nephritis
- Being tested
- ACEI / ARB+finerenone, ACEI/ARB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACEI / ARB+finerenoneDrug
In the finerenone group, finerenone was administered orally on the basis of combined oral ACEI/ARB, with the dose calculated based on body surface area, once a day for 3 months.
ACEI/ARBDrug
The control group was only given oral ACEI/ARB for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone group | Experimental | Not described Receives: Drug: ACEI / ARB+finerenone |
| Control group | Active comparator | Not described Receives: Drug: ACEI/ARB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects with a Reduction in 24-Hour Urinary Protein Excretion ≥30% from Baseline
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start13 Jun 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Henoch Schönlein Purpura NephritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Institute of Pediatrics, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315191
- Sponsor's protocol ID
- BRWEP2024W102100109
- Acronym
- FICHSPN
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized Controlled Trial of Finerenone Therapy for Pediatric Hennoch Scholein Nephritis With Mild Proteinuria
- ClinicalTrials.gov ID
- NCT07315191
- Acronym / sponsor ID
- FICHSPN / BRWEP2024W102100109
- Conditions
- Henoch Schönlein Purpura Nephritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Capital Institute of Pediatrics, ChinaUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 2 Jan 2026 (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.
Henoch-Schönlein purpura nephritis (HSPN) is the most common secondary glomerular disease in children. About 40% of HSPN cases are accompanied by mild proteinuria, and some of them progress to end-stage renal disease. Currently, the treatment for children with mild proteinuria HSPN mainly involves ACEI/ARB, but long-term use of these drugs can lead to an increase in aldosterone levels, affecting therapeutic efficacy. Finerenone can improve vascular endothelial cell dysfunction and renal tissue inflammation and fibrosis, and reduce urinary protein in patients with glomerular diseases. This study intends to conduct an exploratory randomized controlled clinical trial of finerenone in children with HSPN accompanied by a small amount of proteinuria to evaluate the efficacy and safety of finerenone treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finerenone group | Experimental | Drug: ACEI / ARB+finerenone |
| Control group | Active comparator | Drug: ACEI/ARB |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children of HSPN meet the following conditions① Age > 3 years old and < 18 years old;
- 24-hour urine protein quantification >= 8mg/h/M2 body surface area (or >= 300mg/d), and < 20mg/h/M2 body surface area (< 1000mg/d);
- 3: 3. Sign the informed consent form.
Key exclusion criteria (7 listed)
- Abnormal renal function: eGFR < 90 ml/min/1.73m^2 body surface area;
- Renal pathological grade >= IV;
- Application of glucocorticoids and/or immunosuppressants within 2 weeks;
- Recent applications involving high-dose glucocorticoids administered for a duration exceeding two weeks.;
- Liver transaminase > 2 times the upper limit of normal;
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 |
|---|---|---|
| ACEI / ARB+finerenoneIn the finerenone group, finerenone was administered orally on the basis of combined oral ACEI/ARB, with the dose calculated based on body surface area, once a day for 3 months. | Drug | Finerenone group |
| ACEI/ARBThe control group was only given oral ACEI/ARB for 3 months. | Drug | Control group |
Primary outcome
Percentage of Subjects with a Reduction in 24-Hour Urinary Protein Excretion ≥30% from Baseline
Time frame: 3 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 7 Jan 2026.
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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.
Juan Tu contact
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 ACEI / ARB+finerenone and ACEI/ARB in people with Henoch Schönlein Purpura Nephritis, run by Capital Institute of Pediatrics, China 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 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. 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?
Contact Yue Jia (86+13681366590, kamui1127@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects with a Reduction in 24-Hour Urinary Protein Excretion ≥30% from Baseline (time frame: 3 months). 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 7 Jan 2026.