IgA NephropathyPhase 3FIGHTNCT06580288
Effect of Finerenone in IgA Nephropathy
A Phase 3 study testing Finerenone in people with IgA Nephropathy, run by Zhejiang University.
Trial summary
The aim of this trial is to conduct a randomized, multicenter, placebo-controlled, double-blind clinical trial to determine the safety and efficacy of Finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Finerenone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2024to 8 Oct 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney biopsy confirmed IgA nephropathy within 2 years, with secondary IgA nephropathy excluded;
- Age ≥ 18 years;
- Maximum tolerated dose of RAS inhibitors for more than 3 months, with urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g; V1 laboratory test showing urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g. After maximum tolerated dose of RAS inhibitors or ARB, V2 urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g;
- eGFR calculated by EPI ≥ 30 ml/min/1.73 m²;
- Serum potassium level ≤ 4.8 mmol/L;
- SBP ≤ 150 mmHg, DBP ≤ 110 mmHg;
- LVEF > 40%;
- Willing and able to provide informed consent.
Who cannot join
- There are clear indications for the use of immunosuppressive therapy, such as: nephrotic syndrome (urine protein greater than 3.5 g/d, blood albumin less than 30 g/L), pathological minimal change disease combined with IgA nephropathy; the proportion of crescents in kidney biopsy is ≥ 50%.
- Any existing life-threatening condition with a life expectancy of less than 2 years;
- Active infection, HBV infection, or active lesions (nodules, cavities, or tuberculomas);
- AKI causing renal dysfunction;
- Use of steroids/immunosuppressive drugs within the past 3 months;
- History of malignant tumors, regardless of treatment status or evidence of local recurrence or metastasis;
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- Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of the investigational drug;
- History of drug or alcohol abuse within the past 12 months;
- History of drug allergies or contraindications;
- Previous noncompliance or unwillingness to follow the study protocol;
- Any condition that may affect safety or efficacy;
- History of kidney transplantation or currently receiving immunosuppressive treatment;
- Pregnant or breastfeeding women;
- Obese patients with a BMI > 35.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Finerenone in the Treatment of IgA Nephropathy
The aim of this trial is to conduct a randomized, multicenter, placebo-controlled, double-blind clinical trial to determine the safety and efficacy of Finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy.
The primary endpoint event was the change in urinary albumin/creatinine ratio between the two groups at 12 months of treatment.
Read the detailed description
This is a randomized, multicenter, placebo-controlled, double-blind clinical trial aimed at clarifying the safety and efficacy of finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy.
Study population will include participants with renal biopsy confirmed IgA nephropathy (eGFR ≥ 30 mL/min/1.73 m2) and UACR ≥500mg/g ≤3500mg/g. Participants receiving maximum tolerated dose of RAS inhibitor treatment for more than 3 months are eligible for the study.
The study will be conducted at 4 sites. 120 participants will be randomised to one of 2 arms in a 1:1 ratio:
- Finerenone 10mg/20 mg
- Placebo 10mg/20 mg For each participant, the total duration of participation will be approximately 12 months.
- Conditions
- IgA Nephropathy
- Being tested
- Finerenone, Placebo
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
10mg or 20mg
PlaceboDrug
10mg or 20mg
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Experimental | Not described Receives: Drug: Finerenone |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in uACR between the two groups
Measured: at 12months
Secondary outcomes (4)
eGFR slop
Measured: at 12months
change in uPCR between the two groups
Measured: at 12months
renal failure (eGFR decline of 40% or progression to ESKD, defined as initiation of dialysis, kidney transplantation, or eGFR ≤ 15 ml/min/1.73 m²);
Measured: at 12months
cardiovascular event endpoints: cardiovascular death or non-fatal myocardial infarction or non-fatal stroke; hospitalization due to heart failure; major cardiovascular events; all-cause mortality.
Measured: at 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start8 Oct 2024 (estimated)
- Primary completion8 Jun 2026 (estimated)
- Study completion8 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Zhejiang 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Du Xiaoying, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580288
- Sponsor's protocol ID
- IIT20240069C-R1
- Acronym
- FIGHT
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Finerenone in the Treatment of IgA Nephropathy
- ClinicalTrials.gov ID
- NCT06580288
- Acronym / sponsor ID
- FIGHT / IIT20240069C-R1
- Conditions
- IgA Nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 8 Oct 2024 (estimated)
- Primary completion
- 8 Jun 2026 (estimated)
- Study completion
- 8 Oct 2026 (estimated)
- First posted
- 30 Aug 2024 (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.
The aim of this trial is to conduct a randomized, multicenter, placebo-controlled, double-blind clinical trial to determine the safety and efficacy of Finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy.
The primary endpoint event was the change in urinary albumin/creatinine ratio between the two groups at 12 months of treatment.
Detailed description
This is a randomized, multicenter, placebo-controlled, double-blind clinical trial aimed at clarifying the safety and efficacy of finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy.
Study population will include participants with renal biopsy confirmed IgA nephropathy (eGFR ≥ 30 mL/min/1.73 m2) and UACR ≥500mg/g ≤3500mg/g. Participants receiving maximum tolerated dose of RAS inhibitor treatment for more than 3 months are eligible for the study.
The study will be conducted at 4 sites. 120 participants will be randomised to one of 2 arms in a 1:1 ratio:
- Finerenone 10mg/20 mg
- Placebo 10mg/20 mg For each participant, the total duration of participation will be approximately 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finerenone | Experimental | Drug: Finerenone |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Kidney biopsy confirmed IgA nephropathy within 2 years, with secondary IgA nephropathy excluded;
- Age ≥ 18 years;
- Maximum tolerated dose of RAS inhibitors for more than 3 months, with urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g; V1 laboratory test showing urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g. After maximum tolerated dose of RAS inhibitors or ARB, V2 urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g;
- eGFR calculated by EPI ≥ 30 ml/min/1.73 m²;
- Serum potassium level ≤ 4.8 mmol/L;
Key exclusion criteria (14 listed)
- There are clear indications for the use of immunosuppressive therapy, such as: nephrotic syndrome (urine protein greater than 3.5 g/d, blood albumin less than 30 g/L), pathological minimal change disease combined with IgA nephropathy; the proportion of crescents in kidney biopsy is ≥ 50%.
- Any existing life-threatening condition with a life expectancy of less than 2 years;
- Active infection, HBV infection, or active lesions (nodules, cavities, or tuberculomas);
- AKI causing renal dysfunction;
- Use of steroids/immunosuppressive drugs within the past 3 months;
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 |
|---|---|---|
| Finerenone10mg or 20mg | Drug | Finerenone |
| Placebo10mg or 20mg | Drug | placebo |
Primary outcome
change in uACR between the two groups
Time frame: at 12months
4 secondary outcomes
eGFR slop
Time frame: at 12months
change in uPCR between the two groups
Time frame: at 12months
renal failure (eGFR decline of 40% or progression to ESKD, defined as initiation of dialysis, kidney transplantation, or eGFR ≤ 15 ml/min/1.73 m²);
Time frame: at 12months
cardiovascular event endpoints: cardiovascular death or non-fatal myocardial infarction or non-fatal stroke; hospitalization due to heart failure; major cardiovascular events; all-cause mortality.
Time frame: at 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Finerenone in people with IgA Nephropathy, run by Zhejiang University.
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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guizhen Yu (15268801632, gzysmile@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in uACR between the two groups (time frame: at 12months). 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 30 Aug 2024.