What's next in nephrology — October 18, 2026

This issue covers what is coming in nephrology between the third week of October 2026 and April 2027: two phase 3 presentations at ASN Kidney Week (Denver, October 22–25), the public review of the KDIGO CKD guideline focused update, two FDA decisions —povetacicept in IgA nephropathy and imlifidase for desensitization in kidney transplantation— and the interim analysis of inaxaplin in APOL1-mediated kidney disease. Only milestones with a date published by the regulator, the scientific society, the congress or the company are included.

1. ORIGIN 3: final eGFR analysis of atacicept in IgA nephropathy

[Congress] [United States (Denver)] [Confirmed date: October 22, 2026]
What it is: The final efficacy analysis of ORIGIN 3 (NCT04716231; phase 3, randomized, double-blind, placebo-controlled; 428 patients) is presented as a late-breaking abstract at the ASN Kidney Week opening plenary on October 22 (abstract TH-OR109). Per Vera's September 15 release, eGFR slope through 104 weeks was −0.6 vs −5.6 mL/min/1.73 m²/year with placebo (difference 5.0; 95% CI 3.6–6.5), and the composite kidney progression endpoint was reduced by 76% (11 vs 38 events; HR 0.24). Atacicept (TRUTAKNA) received FDA accelerated approval in July 2026 based on proteinuria; Vera plans to file the supplemental application for full approval in Q4 2026.
What problem it solves: Despite RAS blockade, SGLT2 inhibitors, sparsentan and targeted-release budesonide, many patients with IgA nephropathy keep losing filtration; it remained to be shown that targeting BAFF/APRIL (the pathway that produces galactose-deficient IgA1) preserves kidney function rather than just lowering proteinuria.
Critical take: Sponsor trial and sponsor figures, not yet peer-reviewed; eGFR slope is an accepted surrogate, but hard events were few (dialysis, transplant or death: 0 vs 8), and cost and availability in Latin America are unknown.
Source:
https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-origin-3-final-efficacy-analysis
https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-trutaknatm-atacicept-vymj-stabilized
https://www.asn-online.org/education/kidneyweek/2026/meeting-overview.aspx
https://www.sec.gov/Archives/edgar/data/0001831828/000119312526391280/d32300dex991.htm
https://clinicaltrials.gov/study/NCT04716231

2. Intravenous upacicalcet for secondary hyperparathyroidism on hemodialysis

[Ongoing trial] [United States (Denver)] [Confirmed date: October 23, 2026]
What it is: Efficacy and safety results of the phase 3 trials PATH-1 (NCT05832931) and PATH-2 (NCT05836220) —randomized, double-blind, placebo-controlled, with open-label extensions— of upacicalcet, an investigational injectable calcimimetic, in hemodialysis patients with secondary hyperparathyroidism, are presented as a late-breaking oral at ASN Kidney Week on October 23 (abstract FR-OR112). Pathalys has not yet disclosed the results or its regulatory timeline.
What problem it solves: PTH control on dialysis currently relies on oral cinacalcet (nausea, pill burden and poor adherence), intravenous etelcalcetide, vitamin D analogs and, in refractory cases, parathyroidectomy; a calcimimetic given during the dialysis session guarantees the dose is taken.
Critical take: Sponsor trials against placebo rather than another calcimimetic; the expected endpoint is biochemical (PTH lowering), with no data on fractures, cardiovascular events or mortality, and the results are not yet public.
Source:
https://www.prnewswire.com/news-releases/pathalys-pharma-announces-late-breaking-abstract-from-pivotal-phase-3-program-selected-as-featured-oral-presentation-at-asn-kidney-week-2026-302898392.html
https://clinicaltrials.gov/study/NCT05832931
https://clinicaltrials.gov/study/NCT05836220

3. KDIGO 2027 CKD guideline focused update

[Guideline in preparation] [International] [Confirmed date: November 4, 2026 (public review closes)]
What it is: On October 15 KDIGO opened public review of the draft focused update of its CKD guideline, which reviews new evidence on SGLT2 inhibitors, GLP-1-based therapies and nonsteroidal mineralocorticoid receptor antagonists in people with CKD (dialysis and transplant excluded). Review closes on November 4, 2026; KDIGO has not published a date for the final version.
What problem it solves: Evidence of kidney and cardiovascular protection from these three classes has outpaced guidelines, and in practice they remain underused or are started sequentially and late; the guideline aims to clarify when and how to combine them.
Critical take: It is a draft that may change after review; several recommendations rest on industry-sponsored trials, and uptake in our setting will depend on drug cost and coverage.
Source:
https://kdigo.org/kdigo-2027-ckd-guideline-focused-update-public-review-open/
https://kdigo.org/wp-content/uploads/2026/10/KDIGO-2027-CKD-Guideline-Focused-Update-Public-Review-Draft.pdf

4. Povetacicept in IgA nephropathy

[Pending regulatory decision] [United States] [Confirmed date: November 30, 2026]
What it is: The FDA accepted the accelerated approval application for povetacicept, a dual BAFF/APRIL inhibitor given subcutaneously every four weeks, and set a PDUFA date of November 30, 2026. It is based on the 36-week interim analysis of RAINIER (NCT06564142; phase 3, randomized, double-blind, placebo-controlled; 605 adults): proteinuria (UPCR) fell 49.8% vs placebo and galactose-deficient IgA1 fell 79.3%. The final primary endpoint is eGFR slope through 104 weeks.
What problem it solves: The same as item 1: halting the disease at its immunological source in patients with persistent proteinuria despite optimized supportive care; it would be a second drug in the class.
Critical take: Accelerated approval rests on 36-week proteinuria, a surrogate endpoint; the effect on filtration is not yet known, and the trial is sponsored by Vertex.
Source:
https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-acceptance-biologics-license-application
https://clinicaltrials.gov/study/NCT06564142

5. Imlifidase to desensitize highly sensitized kidney transplant candidates

[Pending regulatory decision] [United States] [Confirmed date: December 19, 2026]
What it is: The FDA set December 19, 2026 as the PDUFA date for imlifidase, an IgG-cleaving enzyme that allows transplantation across a positive crossmatch. The pivotal ConfIdeS trial (NCT04935177; phase 3, open-label, randomized; 64 adults with cPRA ≥99.9% and a positive crossmatch against a deceased donor) showed a mean 12-month eGFR of 51.5 vs 19.3 mL/min/1.73 m² in the control arm (p<0.0001) and greater dialysis independence. It holds conditional approval in the European Union.
What problem it solves: Highly sensitized patients may wait years or never receive a compatible kidney; off-label desensitization protocols (intravenous immunoglobulin, rituximab, plasmapheresis) are used today with limited efficacy.
Critical take: A small, open-label trial with a heterogeneous control arm (which included staying on dialysis), favoring the eGFR difference; it requires a deceased-donor program with round-the-clock immunology and monitoring for rebound antibody-mediated rejection.
Source:
https://www.hansabiopharma.com/files/Main/1219/4317024/2026-03-04-bla-fda-pdufa-dec-imlifidase-pr-eng-final.pdf
https://www.inderes.se/en/releases/hansa-biopharma-ab-pdufa-action-date-for-hansa-biopharmas-imlifidase-bla-set-for-december-19-2026
https://news.cision.com/hansa-biopharma-ab/r/imlifidase-successfully-meets-primary-endpoint-in-pivotal-us-phase-3-confides-trial-in-kidney-transp,c4239397
https://clinicaltrials.gov/study/NCT04935177

6. Inaxaplin in APOL1-mediated kidney disease

[Ongoing trial] [International] [Estimated date: early 2027, per Vertex]
What it is: AMPLITUDE is a global phase 2/3 trial of oral inaxaplin 45 mg daily vs placebo, on top of standard care, in people with two APOL1 risk variants, severe proteinuria and no other cause of kidney disease; with enrollment complete, Vertex expects the interim analysis (when the cohort reaches 48 weeks) in early 2027, which could support US accelerated approval. The final primary endpoint is eGFR slope at two years.
What problem it solves: APOL1-mediated kidney disease accounts for much of the excess kidney disease in people of sub-Saharan African ancestry and has no specific therapy today: only RAS blockade and general measures.
Critical take: The interim analysis will likely rely on proteinuria rather than kidney events; the sponsor is Vertex, and although highly relevant to Afro-descendant populations such as much of the Caribbean, it requires APOL1 genotyping, which is scarce in the region.
Source:
https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-positive-results-phase-2b-amplified-study
https://clinicaltrials.gov/study/NCT05312879

*What's next in nephrology — October 18, 2026*

1. ORIGIN 3 (atacicept, IgA nephropathy): final two-year eGFR analysis at the ASN Kidney Week plenary on October 22, 2026.
2. IV upacicalcet (secondary hyperparathyroidism on hemodialysis): phase 3 PATH-1 and 2 at Kidney Week on October 23, 2026.
3. KDIGO CKD guideline (SGLT2i, GLP-1, nonsteroidal MRAs): public review until November 4, 2026.
4. Povetacicept (IgA nephropathy): FDA decision on November 30, 2026.
5. Imlifidase (transplant in highly sensitized patients): FDA decision on December 19, 2026.
6. Inaxaplin (APOL1 kidney disease): AMPLITUDE interim analysis in early 2027.

Each item with an official source and a critical take.
Full issue and audio:
https://boletinesmedicos.com/en/nephrology/2026-10-18-viene.html
MedBulletins · boletinesmedicos.com

What's next in nephrology (October 2026 – April 2027), verifiable dates only:

• October 22, ASN Kidney Week: final ORIGIN 3 analysis of atacicept in IgA nephropathy (two-year eGFR slope).
• October 23: phase 3 of IV upacicalcet for secondary hyperparathyroidism on hemodialysis.
• Until November 4: public review of the KDIGO CKD update on SGLT2i, GLP-1 and nonsteroidal MRAs.
• November 30: FDA decision on povetacicept in IgA nephropathy.
• December 19: FDA decision on imlifidase for transplanting highly sensitized patients.
• Early 2027: interim analysis of inaxaplin in APOL1-mediated kidney disease.

Each item covers the problem it solves and an honest critical take.
https://boletinesmedicos.com/en/nephrology/2026-10-18-viene.html

#Nephrology #IgANephropathy #KidneyTransplant #CKD #KidneyWeek

What's next in nephrology: ORIGIN 3 at Kidney Week 10/22; upacicalcet 10/23; KDIGO CKD review until 11/4; FDA decides povetacicept 11/30 and imlifidase 12/19; inaxaplin (APOL1) in early 2027.
https://boletinesmedicos.com/en/nephrology/2026-10-18-viene.html