Who is sponsoring NCT05795140?

NCT05795140 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT05795140?

Interventions in NCT05795140: Iptcaopan 200 mg.

What condition does NCT05795140 study?

NCT05795140 studies Atypical Hemolytic Uremic Syndrome.

Is NCT05795140 still recruiting?

NCT05795140 is currently recruiting now. Last updated 16 July 2025.

Last reviewed 2025-07-16 · How we verify

NCT05795140

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS

Recruiting now Phase 3 Last updated 16 July 2025

What this trial tests

Phase 3 trial testing Iptcaopan 200 mg in Atypical Hemolytic Uremic Syndrome in 125 participants. Currently enrolling.

Timeline

8 May 2024

Primary endpoint
23 December 2032

3 January 2033

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	125
Start date	8 May 2024
Primary completion	23 December 2032
Estimated completion	3 January 2033
Sites	6 locations across China, India, Brazil, Czechia

Drugs / interventions tested

Iptcaopan 200 mg — full drug profile →

Conditions studied

Atypical Hemolytic Uremic Syndrome — all drugs for Atypical Hemolytic Uremic Syndrome →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 100, any sex, with Atypical Hemolytic Uremic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, single arm, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of iptacopan in participants with aHUS.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young Children: Results from an Open-Label, Single-Dose, Cross-Over Study.
Münch J, Sessler I, Bosse HM, Wargenau M, et al · · 2023 · cited 6× · PMID 37376177 · DOI 10.3390/pharmaceutics15061729
Post-transplant Thrombotic Microangiopathy.
Java A, Java A, Sparks MA, Kavanagh D. · · 2025 · cited 4× · PMID 39888686 · DOI 10.1681/asn.0000000645
Advancements in complement inhibition for PNH and primary complement-mediated thrombotic microangiopathy.
Padilla Kelley T, King H, Malhotra A, DeLoughery TG, et al · · 2025 · cited 2× · PMID 40354320 · DOI 10.1182/bloodadvances.2024015777
Targeting the Roots of Kidney Disease: Systematic Review of the Therapies Targeting the Complement System.
Roman M, Nowicki M. · · 2025 · cited 1× · PMID 40731834 · DOI 10.3390/medicina61071205
Targeted Complement Treatments in Glomerulopathies: A Comprehensive Review.
Gentile M, Manenti L. · · 2025 · cited 1× · PMID 39941374 · DOI 10.3390/jcm14030702

Verify or expand the search:

Other recruiting trials for Atypical Hemolytic Uremic Syndrome

Currently open trials in the same condition.

NCT07308574 — Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS · Phase 4 · recruiting
NCT07218536 — The Burden of Atypical Hemolytic Uremic Syndrome and The Clinical Characteristics of Patients in Egyptian Hospitals A Mu · recruiting
NCT05935215 — Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With Atypi · Phase 3 · recruiting
NCT05805202 — Functional Implications of Rare Gene Mutations in aHUS Open the Door to Personalized Therapy · NA · recruiting
NCT04889430 — Efficacy and Safety of Iptacopan (LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive to Complement · Phase 3 · active not recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05795140 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 16 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05795140.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing