New Pill Option for Kidney Disease in Adults With Type 1 Diabetes

Kerendia (finerenone) is a once-daily oral tablet. On the US Prescribing Information (Bayer labeling, Revised: 9/2026; Recent Major Changes Indications and Usage 9/2026) it is indicated to:

• reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adults with CKD associated with type 2 diabetes mellitus (T2DM);
• reduce UACR, which is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease in adults with CKD associated with type 1 diabetes mellitus (T1DM); and
• reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure with LVEF ≥40%.

This draft is about the new adult CKD + type 1 diabetes door. The T2D outcomes and heart-failure doors remain on the same USPI but are not the expansion being walked here.

This is a traditional FDA supplemental approval of a product first approved in 2021. Bayer announced FDA approval of the T1D CKD indication on 17 September 2026 after Priority Review of an sNDA. Applicant framing: Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ. NDA family 215341.

Honesty on the endpoint: For T1DM, the labelled claim is UACR reduction, with kidney-outcome benefit described as expected — bridged from Kerendia’s established kidney-outcome evidence in CKD+T2DM (FIDELIO-DKD / FIGARO-DKD) plus FINE-ONE pharmacodynamic and safety data in T1DM. That is not the same sentence as a completed hard-outcome T1D kidney-failure trial on this carton.

Distinct path — not this carton (fact-only): Kerendia’s CKD + type 2 diabetes outcomes indication and the heart failure LVEF ≥40% indication are separate labelled conversations on the same brand. Steroidal MRAs and other diabetes kidney medicines have separate labels. Today’s US labelled once-daily oral door specifically for adults with CKD associated with type 1 diabetes (UACR reduction / expected kidney-outcome language) is Bayer Kerendia.

Manufactured / marketed in the US by Bayer HealthCare Pharmaceuticals Inc.

Where this is taking place

Commercial labelled door today: United States — FDA-labelled Kerendia for adults with CKD associated with T1DM, prescribed through a diabetes / endocrinology / nephrology / primary-care clinician able to order eGFR and serum potassium, confirm ACE inhibitor or ARB background care, and arrange pharmacy / Bayer patient-support logistics. Existing US commercial tablet supply applies. This is a prescription oral add-on conversation — not a DIY import and not a claim that urine-protein change equals guaranteed dialysis avoidance.

Outside the United States: As of this draft, no confirmed Health Canada Product Monograph text, European Commission marketing authorisation, MHRA licence, TGA listing, Swissmedic authorisation, or PMDA/MHLW licence for this T1D CKD indication. Existing foreign Kerendia licences for other uses, if any, are not automatically this expansion. FINE-ONE sites in other countries are not a foreign T1D carton. Do not import on your own.

FINE-ONE — NCT05901831 — Phase 3, randomized, double-blind, placebo-controlled, multicenter study in adults with CKD associated with T1DM. Lead sponsor: Bayer. CT.gov status at draft time: COMPLETED. Actual enrolment 241 (PI states 242 adults). Actual start 26 Feb 2024; actual primary completion 20 Aug 2025; actual study completion 15 Sep 2025. Locations include the United States, Canada, China, Denmark, Germany, Italy, South Korea, Spain, and United Kingdom among listed countries. Expanded access: CT.gov reports hasExpandedAccess: false. Honesty: A completed pivotal study supports the label — that is not open new enrolment, and Canadian trial sites are not a Canadian T1D Product Monograph.

The practical commercial door in the US is a clinician who can confirm type 1 diabetes + CKD with albuminuria, check potassium and eGFR before starting, review drug interactions (especially strong CYP3A4 inhibitors), plan once-daily dosing and lab follow-up, and arrange payer / Bayer support if needed.

Approval matrix

Access by country

• United States: Ask a diabetes / endocrinology / nephrology / primary-care clinician about FDA-labelled Kerendia for this type 1 diabetes CKD door. Labelled September 2026 to reduce UACR (expected to reduce sustained eGFR decline and end-stage kidney disease) in adults with CKD associated with T1DM. Recommended CKD+T1DM dosage family: measure eGFR and serum potassium before start; do not initiate if potassium >5.0 mEq/L; start 20 mg once daily if eGFR ≥60, or 10 mg once daily if eGFR ≥25 to <60; initiation not recommended if eGFR <25; target dose 20 mg once daily with potassium-based adjustment after about 4 weeks (see PI Table 2). Tablets with or without food; may crush/mix with water or soft food immediately before use if needed. Example bottles: NDC 50419-540-01 (10 mg/30), 50419-540-02 (10 mg/90), 50419-541-01 (20 mg/30), 50419-541-02 (20 mg/90). Suspected adverse reactions: Bayer HealthCare Pharmaceuticals 1-888-842-2937 or FDA MedWatch 1-800-FDA-1088. Patient support navigation: 1-888-KERENDIA (1-888-537-3634) (company materials: Mon–Fri 9:00 AM–6:00 PM ET) / kerendia-us.com savings-and-support pages. No list price or copay dollars in this article. This is US commercial labelled supply, not a DIY import.

• Canada: This T1D Kerendia authorisation is not confirmed. Ask the Canadian diabetes / kidney clinic what legal paths exist in Canada when a Canadian label for this T1D use is not confirmed. An existing Canadian carton for another indication, if present, is not automatically this expansion.

• European Union / United Kingdom / Australia / Japan / other countries: Regulator authorisation for this T1D CKD use is not confirmed in this draft. Completed trial sites are not a commercial foreign carton for the new use. Do not import on your own.

• If your regulator has not authorised this use: do not import on your own. Ask the local clinician about documented special-access / named-patient rules, referral to a centre in a labelled country, or waiting — without treating a US bottle as a foreign carton for this expansion.

Who is eligible (from the US label)

This is an adult CKD + type 1 diabetes conversation on the Prescribing Information for the new door — UACR reduction with expected kidney-outcome language — not a collapse into the T2D outcomes carton or the heart-failure carton.

United States (Bayer USPI, revised September 2026):

• Indication (this draft): Reduce UACR, which is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease, in adults with CKD associated with T1DM.
• Recommended dosage (CKD + T1DM): Start by eGFR (20 mg if ≥60; 10 mg if ≥25–<60); target 20 mg once daily; potassium-based titration; do not start if K+ >5.0.
• Contraindications: Hypersensitivity to any component; concomitant strong CYP3A4 inhibitors; adrenal insufficiency.
• Warnings: Hyperkalemia (monitor potassium / eGFR); worsening of renal function in patients with heart failure (HF dosing rules differ — not this door’s focus).
• Most common adverse reactions (≥1% and more than placebo on class labeling): hyperkalemia, hypotension, hyponatremia.
• FINE-ONE population (USPI): Adults with CKD + T1DM; UACR ≥200 to <5000 mg/g; HbA1c <10%; eGFR 25 to <90; serum potassium ≤4.8 at screening; continuous insulin; stable ACE inhibitor or ARB; SGLT2 inhibitors and GLP-1 receptor agonists excluded from the trial.
• Pediatrics: Not established for this T1D CKD door on sources used here (adult indication text).

Not labelled on sources confirmed for this draft:

• Proven hard end-stage-kidney-disease outcome superiority in a dedicated T1D kidney-failure trial (label uses UACR + expected outcome language).
• This T1D expansion in Canada, the EU, UK, Japan, Australia, or Switzerland (not confirmed here).
• Using the heart-failure 40 mg target pathway as the CKD+T1DM target (CKD+T1DM target is 20 mg).
• Treating NCT05901831 as open commercial enrolment.

What the pivotal study showed (USPI / company)

Use the USPI for a prescription conversation. Journals are supportive reading.

FINE-ONE — NCT05901831 (USPI §14.2):

• Randomized Kerendia (N=120) vs placebo (N=122) for about 6 months.
• Primary endpoint: change in log-transformed UACR from baseline averaged over Months 3 and 6.
• Month 3: placebo-adjusted relative UACR reduction 22% (LSGMR 0.78; 95% CI 0.68–0.90).
• Month 6: placebo-adjusted relative UACR reduction 28% (LSGMR 0.72; 95% CI 0.60–0.86).
• Overall primary comparison p 0.0001.
• Safety profile described as consistent with CKD+T2DM experience; company announcement reports hyperkalemia 10.1% vs 3.3% placebo, with discontinuation for hyperkalemia 1.7% vs 0%.

Detailed FINE-ONE results were also published in the New England Journal of Medicine (2026;394(10):947-957).

How to talk with a doctor

Bring this page and ask a diabetes / kidney clinician:

1. “I have type 1 diabetes and CKD with albuminuria. Does labelled US Kerendia for this T1D door fit on top of my ACE inhibitor / ARB?”
2. “What are my current eGFR and serum potassium, and how often would you recheck them?”
3. “How should we read the label’s UACR / expected kidney-outcome language for my goals?”
4. “Do any of my medicines interact (especially strong CYP3A4 inhibitors or potassium-raising drugs)?”
5. If outside the US: “Has our regulator authorised this T1D use, or what legal special-access options exist?”

Who is involved (from primary sources)

• Sponsor / manufacturer: Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ (USPI).
• Pivotal trial: FINE-ONE (NCT05901831) — Bayer-sponsored Phase 3 program supporting the US T1D CKD label.
• Study leadership named in company announcement: Dr. Janet McGill, Washington University School of Medicine in St. Louis — Co-Chair of the study’s Executive Committee (Bayer 17 Sep 2026 announcement).
• Patient / AE contacts (company): Bayer AE 1-888-842-2937; Kerendia Patient Support 1-888-537-3634.

Names and roles above are limited to what appears on the primary sources cited. Contacts not listed on those sources are omitted.

Sources

1. Bayer HealthCare Pharmaceuticals — KERENDIA (finerenone) Prescribing Information, Revised: 9/2026 (Indications §1; Dosage §2; Clinical Studies §14.2 FINE-ONE).
2. Bayer Corporation announcement — FDA approval of Kerendia for CKD associated with type 1 diabetes, 17 September 2026.
3. ClinicalTrials.gov — NCT05901831 (FINE-ONE).
4. Heerspink HJL et al. Finerenone in type 1 diabetes and chronic kidney disease. N Engl J Med. 2026;394(10):947-957.
5. Drugs@FDA overview for NDA 215341 (historical supplements; T1D supplement index lag noted for Access/Reviewer).

Not medical advice. Talk with a clinician who knows the full history before any treatment decision. Authorized is not funded.