Kidney preservation and earlier detection

October 8 Bayer announcement — filing acceptance. FDA accepted the supplemental application for finerenone/Kerendia in adults with CKD without diabetes receiving standard care. This is a regulatory milestone based on the existing randomized phase 3 FIND-CKD (NCT05047263) results, not a newly run trial or a newly approved indication.

For context, FIND-CKD included 1,584 adults, comparing finerenone with placebo on maximally tolerated ACE inhibitor/ARB treatment. Prior results showed a 0.7 mL/min/1.73 m²/year slower eGFR decline and a composite kidney/cardiovascular benefit; these earlier findings retain their original dates. Hyperkalemia remains a relevant harm.

U.S. status: Finerenone is not yet approved for CKD without diabetes. Existing diabetes-associated CKD and heart-failure indications remain separate. Neither the global nor U.S. release discloses an FDA decision target date. The U.S. webpage is headed October 9 but its release dateline is October 8; use October 8 for this event.

Sources: Primary source 1; Primary source 2.

October 7 ASX announcement, not the October 8 secondary-news date. PYC-003 is an investigational peptide–oligonucleotide approach to PKD1-associated ADPKD, not general acquired CKD.

At day 14 after a single dose, seven patients with usable paired samples had a pooled urinary PC1/CD133 geometric mean fold-change of 1.46 (95% CI 1.11–1.92; paired log-transformed t-test p<0.05): three received 1.2 mg/kg and four 2.4 mg/kg. Small cohorts cannot establish dose response. This is target engagement, not demonstrated preservation of eGFR or avoidance of dialysis.

Exploratory three-month kidney-volume data involve 18 single-dose patients, graphically compared with illustrative historical untreated progression, not a randomized concurrent comparator. Exact plotted kidney-volume values/intervals are not printed numerically; none are inferred here. The ASN abstract reports early safety/PK without treatment-related serious events, not established long-term safety. No U.S. approval.

Next: scheduled ASN presentation October 22, 2026, abstract TH-OR060, 5:20–5:30 p.m. conference-local time in Denver. Sponsor forecasts repeat-dose/open-label-extension data in calendar 2027, with no quarter/day promised.

Sources: Primary source 1; Primary source 2; Primary source 3.

Baseline/site-status recovery, checked October 9; page is undated. Tufts Medicine lists Novartis CCYX082A12301 as recruiting now for a randomized double-blind placebo-controlled phase 3 farabursen study in adults with ADPKD. The investigator is Dana Miskulin.

The site describes 104 weeks of treatment, subcutaneous farabursen 150 or 300 mg every two weeks versus placebo, with kidney-volume growth and kidney-function decline as objectives. It specifies Mayo imaging classes 1C–1E and eGFR eligibility; the local page is not a complete protocol or a verified national enrollment count.

An October 8 Reddit comment claiming Tufts recruitment has an independently matching investigator listing. Its older secondhand October/January start predictions are not global sponsor commitments. This does not establish a new efficacy readout, first patient dosed, or U.S. approval. Verify the complete registered protocol and actual program start; no source-verified readout date is supplied.

Sources: Primary source 1; Primary source 2.

Remaining gaps: Window: September 5–October 9, 2026, retaining the seven-day overlap from the last full successful check on September 12. October 6 findings were deduplicated.; 93 named NCT records across the ten topics and ten discovery queries downloaded successfully through the ClinicalTrials.gov public API. Download is not a claim that all fields/safety/results were exhaustively appraised.; Focused review only. Do not advance full successful-check timestamps or label incomplete remaining searches as no news.; Kidney discovery returned 330 records; first 100 downloaded; selected relevant records screened, remainder not completed. Existing REMODEL null primary outcomes, combination registrations and SCD-PED conference milestone retained rather than repeated. Farabursen full registry not reconciled. PYC-003 exact kidney-volume plotted values unavailable numerically; no visual digitization performed.

Informal-source coverage: Original August 9 ADPKD thread, updated October 8, reviewed via indexed comments; Tufts recruitment claim cross-checked at investigator site. Older nephrologist messages are secondhand and conflict on timing. No clinically reliable efficacy inference drawn. Broader kidney podcast/talk transcripts remain incomplete.

Full coverage record.

Source/event date: October 1, 2026. Evidence: peer-reviewed randomized mechanistic trial. REMODEL randomized 106 adults with type 2 diabetes and CKD (71 semaglutide, 35 placebo; 25 women) across eight countries for 52 weeks. The three coprimary MRI measures—oxygenation, global perfusion and T1 mapping—did not significantly differ. Secondary renal artery resistive index favored semaglutide (ratio 0.96, 95% CI 0.93–0.99), as did cortical diffusion (1.05, 1.01–1.09). Exploratory UACR was 40% lower (ratio 0.60, 0.41–0.88).

The analysis assumes treatment adherence; multiple comparisons had no multiplicity correction. Biopsy analyses involved 33 participants. These mechanistic/biomarker findings do not independently establish less dialysis or additive combination benefit. Adverse-event discontinuation was 9/71 (12.7%) versus 1/35 (2.9%); serious-event rates were similar. This paper creates no new U.S. indication; existing semaglutide indications are separate. Next mechanistic replication/publication date is unannounced.

Nature · article · ClinicalTrials.gov · NCT04865770 · ClinicalTrials.gov · NCT04865770

Source/event date: September 30, 2026. Evidence: new trial registration. A planned 266-person randomized quadruple-masked trial compares finerenone plus semaglutide with finerenone placebo plus semaglutide in non-diabetic adults with excess adiposity, CKD and albuminuria. The primary endpoint is UACR change at 24 weeks; filtration, albuminuria categories and safety are secondary. NOT_YET_RECRUITING; September 2026 start and February 2027 completion remain estimates despite the elapsed start month. No results are posted. This extends the combination question beyond diabetes; short-term albuminuria is not kidney-failure prevention. No new combination or non-diabetic CKD U.S. indication is established.

ClinicalTrials.gov · NCT07849348 · ClinicalTrials.gov · NCT07849348

Source/event date: September 30, 2026. Evidence: phase 3 registration. A 340-person randomized double-masked trial plans to compare zigakibart plus atrasentan with zigakibart plus placebo in adults with biopsy-proven primary IgA nephropathy. The primary endpoint is 24-hour proteinuria change at week 36; eGFR through 104 weeks and adverse/serious/special-interest events through 128 weeks are secondary. NOT_YET_RECRUITING, with December 1, 2026 estimated start, September 17, 2028 primary completion and December 25, 2030 final completion. No results. This is prospective combination evidence and creates no new U.S. approval; proteinuria remains separate from kidney failure.

ClinicalTrials.gov · NCT07850752 · ClinicalTrials.gov · NCT07850752

Source date: October 5, 2026; actual study start: August 20. Evidence: newly posted older-start registration. A planned 1,500-person U.S. prevention study randomizes primary-care providers to patient letters, letters plus calls, or augmented usual care following a CKD risk-model alert. Its primary outcome is days to completion of either eGFR or UACR testing over 12 months; time to CKD diagnosis is secondary. RECRUITING; primary completion August 20, 2027 and final completion December 31, 2027 are estimates.

This is useful screening/implementation research, not a newly started October study or evidence that the model prevents kidney failure. Completing one test is not the same as evaluating both filtration and albuminuria. No benefit or safety results are posted; testing burden, false positives and downstream care remain prospective.

ClinicalTrials.gov · NCT07857200 · ClinicalTrials.gov · NCT07857200

Source/event date: October 2, 2026. Evidence: sponsor-announced presentation schedule. SeaStar announces SAVE post-authorization SCD-PED registry data compared with a historical pediatric sepsis-associated AKI cohort at ASN Kidney Week. Poster TH-PO1291 is scheduled October 22, 2026, 10:00 a.m.–noon Mountain Time. The announcement provides no sample size, effect estimate, confidence interval or new safety table. A historical comparator cannot establish randomized causal benefit. FDA’s February 21, 2024 HDE letter independently confirms authorization (BH220740) for patients weighing ≥10 kg and aged ≤22 with sepsis-associated AKI on antibiotics requiring renal replacement therapy. This historical humanitarian-device authorization is distinct from a new broad efficacy approval or an adult indication. Next: retrieve the actual poster and denominators; do not treat its title as a positive result.

GlobeNewswire · news release

FDA product page · FDA HDE approval letter

Source/event date: 2026-09-23. Evidence: Peer-reviewed phase 2 publication; recovered September report.

The September 23 Explore-CKD paper reports a randomized masked crossover trial in 59 adults with uncontrolled hypertension, CKD and albuminuria. Lorundrostat 25 mg daily was added to SGLT2 inhibition and ACE-inhibitor/ARB background treatment. Four weeks of treatment lowered office systolic blood pressure by 7.5 mmHg versus placebo; albuminuria also fell. This publishes a trial previously announced at topline in 2025, not a new trial launch. Four-week biomarker changes do not establish sustained kidney preservation or fewer dialysis events. Full adverse-event and interval tables were not appraised here, so comparative safety is unresolved in these notes. No new U.S. approval is established. A separate long-term Transform-HTN extension presentation is announced for AHA November 6–9; its selected prior-trial population differs from a new placebo-controlled outcomes trial.

Next milestone: Transform-HTN AHA November 6–9, 2026 — announced presentation window.

PubMed · PMID 42778148; sciencedirect.com · article; ir.mineralystx.com · news release.

Source/event date: 2026-09-30. Evidence: Trial registry update.

NCT06926660 now lists actual completion August 14, 2026 and enrollment of 492, in the September 30 record. It compares simultaneous versus staggered vicadrostat/empagliflozin initiation, with short-term eGFR, albuminuria, blood-pressure and potassium measures. No results are posted. This phase 2 study is distinct from the stopped EASi-KIDNEY phase 3 outcomes trial; administrative completion does not reverse the September stopping decision or establish benefit. Results-publication timing and new U.S. approval are not established.

Next milestone: Results publication undated.

ClinicalTrials.gov · NCT06926660.

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• DR10624 adds a triglyceride trial in diabetic kidney disease.

Source date: 2026-09-23. Event date: 2026-09-23. Evidence: Sponsor Phase 3 interim topline.

IMAgINATION met its 37-week urine-protein endpoint; clinical kidney-function follow-up remains pending. NCT05797610 enrolled 459 adults with primary IgA nephropathy at progression risk, randomized 1:1 to monthly subcutaneous sefaxersen or placebo. This liver-directed antisense treatment reduces complement factor B.

Limitations: No effect magnitude, confidence interval, p-value or analyzed interim denominator disclosed. Proteinuria reduction does not establish fewer dialysis, transplant or kidney-failure events.

Safety: Sponsor reports consistency with earlier safety and no new signal, without numerical event table.

U.S. status: Investigational.

Next milestone: Blinded follow-up continues to week 105 for eGFR; full interim congress disclosure and regulatory submissions undated. Registry overall completion estimate March 31, 2029.

Roche September 23 IMAgINATION announcement; IMAgINATION registry.

Source date: 2026-09-15. Event date: 2026-09-15. Evidence: Sponsor trial-discontinuation announcement.

Following independent DMC advice, Boehringer discontinued the vicadrostat-plus-empagliflozin trial because accumulating data did not support a meaningful expectation of benefit on its primary composite. Phase 3 NCT06531824 in CKD compared vicadrostat plus empagliflozin with empagliflozin alone; planned enrollment 11,000. The composite includes kidney progression, heart-failure hospitalization or cardiovascular death. September 22 registry remains active/not recruiting with December 31 closeout estimates, despite the September 15 stopping announcement.

Limitations: No hazard ratio, event counts or detailed safety analysis disclosed; do not invent a quantified harm signal. This older missing event is not a September 22 result.

Safety: Benefit-risk review supported stopping; detailed analyses ongoing. Other EASi trials were separately reviewed and continue unchanged.

U.S. status: Vicadrostat remains investigational. Empagliflozin's approved uses and established benefit-risk profile are unchanged.

Next milestone: Detailed analyses and final publication undated; registry administrative closeout estimate is not a result-release promise.

Boehringer September 15 discontinuation; NCT06531824 registry.

Source date: 2026-09-15. Event date: 2026-09-15. Evidence: Sponsor topline announcement in SEC filing.

In 428 adults with primary IgA nephropathy, atacicept's final analysis reported slower filtration decline and fewer composite kidney-progression events. At 52 weeks eGFR change was −0.1 versus −5.7 mL/min/1.73 m²; difference 5.6 (95% CI 3.7–7.5). Annualized slope through 104 weeks: −0.6 versus −5.6; difference 5.0 (3.6–6.5). Composite progression: 11 versus 38 events; HR 0.24 (0.12–0.48). NCT04716231.

Limitations: Sponsor-only final analysis; detailed congress report pending. Historical registry still lists 376 estimated participants, superseded by 428 analyzed. These are IgAN findings, not all-cause CKD prevention.

Safety: Sponsor reports similar overall AE/infection rates and no opportunistic infections or clinically relevant hypogammaglobulinemia; detailed final-arm table absent. Existing label warns of immunosuppression/infection and injection reactions.

U.S. status: TRUTAKNA has accelerated approval for reducing proteinuria in adults with primary IgAN at progression risk; full approval is not yet established.

Next milestone: Supplemental BLA planned Q4 2026; potential full approval in 2027 is a sponsor expectation, not FDA commitment.

Vera September 15 SEC press-release exhibit; Vera September 15 8-K numeric table; NCT04716231 registry.

Source date: 2026-09-14. Event date: 2026-09-14. Evidence: Sponsor first-patient-dosed announcement.

Akebia announced the first patient dosed in its Phase 2 trial across IgA nephropathy, lupus nephritis and C3 glomerulopathy. Ebribafusp, formerly AKB-097/ADX-097, is a tissue-targeted anti-C3d/factor-H fusion protein. NCT06419205: open-label, approximately 30 participants, weekly subcutaneous treatment for 26 weeks; primary safety endpoint, secondary UPCR/eGFR/PK. Registry lists actual study start July 30; September 14 is the announcement date.

Limitations: No patient efficacy result. The proposed infection-risk advantage over systemic complement blockade remains unproven.

Safety: Safety/tolerability is the primary question; earlier healthy-volunteer tolerability cannot establish safety in kidney disease.

U.S. status: Investigational.

Next milestone: Initial data in 2027, sponsor forecast; February 2028 registry completion estimate.

Akebia September 14 first-dose announcement; NCT06419205 registry.

Source date: 2026-09-17. Evidence: Regulatory action; September 2026 U.S. prescribing information verified.

The formerly pending type 1 diabetes indication is now approved. The label specifically describes UACR reduction expected to reduce sustained eGFR decline and end-stage kidney disease. FINE-ONE randomized 242 adults and measured albuminuria over six months. The new label infers kidney-event benefit from type 2 diabetes outcome trials together with pharmacodynamic and safety evidence in type 1 diabetes. The approval expands the indication; it does not represent a new trial directly demonstrating dialysis prevention.

Limitations: Bayer announced the approval on September 17; the dated FDA action letter was not retrieved. The indication should not be generalized to all non-diabetic CKD.

Safety: Hyperkalemia remains the principal monitoring issue; strong CYP3A4 inhibitors and adrenal insufficiency are contraindications. Pooled 14% versus 6.9% hyperkalemia figures in the label belong to type 2 diabetes trials, not FINE-ONE.

U.S. status: Approved in the U.S. for adults with CKD associated with type 1 diabetes.

Next milestone: Implementation and longer-term evidence; no firm date for the next readout was verified.

Bayer U.S. announcement; U.S. prescribing information, revised September 2026.

Source date: 2026-09-14. Evidence: New retrospective trial registration.

A newly posted human trial will be followed for results; it is not a new trial launch. NCT07819227 was first posted on September 14. The open-label, randomized phase 2 crossover study enrolled 41 participants, started on February 11, 2025 and completed on August 31, 2026. Its primary endpoint is the proportion achieving at least a 30% reduction in UACR during single-drug or combination treatment through week 37.

Limitations: Registered after completion, without posted results. Albuminuria endpoint is not kidney-failure prevention.

Safety: No trial results available.

U.S. status: No new combination indication established.

Next milestone: Publication or posted results undated.

NCT07819227 current primary registry.

Related findings:

• Older missing ZEUS negative outcome and infection signal: Ziltivekimab lowered inflammation but did not lower MACE in ZEUS.