New drug hopes to shield transplanted kidneys from protein damage
NCT ID NCT07356388
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether finerenone can reduce protein in the urine (proteinuria) of people who have had a kidney transplant. Proteinuria is a sign of kidney damage. The study compares finerenone plus standard care to dapagliflozin plus standard care in 54 adult patients. The main goal is to see if finerenone lowers urine protein levels and is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Finerenone
- What this could lead to
- If it works, finerenone could offer a new way to reduce proteinuria and protect kidney function in transplant recipients, potentially delaying further kidney damage.
- What could go wrong
- This is a small, early-phase trial with only 54 participants. The drug may not outperform the standard treatment, and side effects like high potassium or kidney issues are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Adult kidney transplant patients (≥18 years old) 2. The diagnosis and screening of chronic kidney disease (CKD) after kidney transplantation meet at least one of the following criteria: 1. Persistent high proteinuria (UACR of 30-300 mg/g, more than 2 of 3 early morning urination samples) and estimated glomerular filtration rate (eGFR) of 25-60ml/min/1.73m2 (CKD EPI) and the presence of diabetic retinopathy. 2. Persistent extremely high albuminuria (UACR≥300mg/g, more than 2 of 3 early morning urination samples) and eGFR≤25 mL /min/1.73m2 (CKD EPI) 3. Previous treatments with angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor block (ARB) are as follows: A. At least 4 weeks prior to the run-in visit, subjects should receive ACEI or ARB or a combination of both b. At the beginning of the run-in visit, subjects were receiving only ACEI or ARB or a combination of both. c. At least 4 weeks prior to the screening visit, subjects should be treated with only the maximum tolerated labeled dose (but not less than the minimum labeled dose) of ACEI or ARB, preferably without adjustment of dose or drug selectivity or any other antihypertensive or antiglycemic therapy. 4\. Serum potassium ≤4.8mmol/L during running-in and screening. 5. Voluntarily sign informed consent Exclusion Criteria: * 1\. Kidney transplant recipients have a history of retransplantation, multiple kidney transplants, and transplantation of other organs and tissues. 2\. Known significant non-diabetic nephropathy, including clinically relevant renal artery stenosis. 3\. Uncontrolled arterial hypertension (i.e. mean sitting systolic blood pressure (SBP) ≥170mmHg at presentation, sitting diastolic blood pressure (DBP) ≥110mmHg, or mean sitting SBP≥160mmHg, sitting DBP≥ 100mmHg at screening) 4. In patients with type I diabetes, the hemoglobin a1C (HbA1c) is \>12%. 5. Uncontrolled hypotension; The mean SBP at run-in visit or screening visit was \<90mmHg 6. Chronic heart failure clinically diagnosed at run-in visit with decreased ejection fraction (HFrEF) and persistent symptoms (New York Heart Association \[NYHA\] Grade II-IV) (Level 1A recommendation for salocorticoid receptor antagonist MRA) 7. Hospitalization for stroke, transient ischemic attack, acute coronary syndrome, or worsening heart failure within 30 days prior to screening 8. Hemokalium was higher than 5.5mmol/L within 12 weeks after treatment due to acute renal failure 9. Patients with malignant tumors or other metabolic disorders have a history of allergic diseases or allergies 10. Severe liver damage 11 Pregnant or lactating women 12. Severe infectious diseases 13. There are other circumstances that the investigator deems inappropriate to participate in the clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, 200082, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.