Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
NCT05935215 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-04-29
Summary
The purpose of this Phase 3 study is to evaluate the efficacy and safety of iptacopan upon switching from anti-C5 antibody to iptacopan treatment in study participants with aHUS.
Conditions
- Atypical Hemolytic Uremic Syndrome
Interventions
- DRUG
-
Open Label
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-28
- Primary Completion
- 2028-07-21
- Completion
- 2029-07-19
- FDA Drug
- Yes
Countries
- China
- France
- Germany
- Italy
- Japan
- Spain
- Turkey (Türkiye)
- United Kingdom
Study Locations
More Related Trials
-
Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients
NCT00658359 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts
NCT05369975 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients
NCT00820911 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation
NCT00492869 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Novel Desensitization Kidney Transplantation
NCT05345717 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation
NCT00359814 ·Status: COMPLETED ·Phase: NA
-
A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients
NCT00543569 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients
NCT00048152 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications
NCT04877288 ·Status: RECRUITING ·Phase: PHASE3
-
24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients
NCT00555789 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
NCT05983770 ·Status: COMPLETED ·Phase: PHASE2
-
A Belatacept Compassionate Use Study for Patients With a Kidney Transplant
NCT00719225 ·Status: NO_LONGER_AVAILABLE
-
CCFZ533X2201 - PoC Study in de Novo Renal Transplantation
NCT02217410 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group
NCT05937750 ·Status: RECRUITING ·Phase: PHASE3
-
Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome -Associated Multiple Organ Dysfunction Syndrome in Hematopoietic Stem Cell Transplant Recipients
NCT03518203 ·Status: COMPLETED ·Phase: PHASE2
-
An Open Label Study to Evaluate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Maintenance Renal Transplant Recipients
NCT00239044 ·Status: COMPLETED ·Phase: PHASE3
-
Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN
NCT04572854 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
NCT04294459 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
NCT00251004 ·Status: COMPLETED ·Phase: PHASE3
-
Carfilzomib and Belatacept for Desensitization
NCT05017545 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Calcineurin Free Immunosuppression in Renal Transplant Recipients
NCT00812123 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension
NCT03781414 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients
NCT00504543 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation
NCT00048165 ·Status: COMPLETED ·Phase: PHASE4
-
Reduced-dose Alemtuzumab for Kidney Transplant Rejection
NCT06100965 ·Status: RECRUITING