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A Study of Complement 3 Glomerulopathy (C3G) Patients Treated With Iptacopan Through an Early Access Program in Spain (ROUTE-C3G)

16 september 2026 bijgewerkt door: Novartis Pharmaceuticals

Clinical Experience With Iptacopan in Adult Patients With Complement 3 Glomerulopathy (C3G): A Multicenter, Observational, Retrospective Study of Patients Treated Through an Early Access Program in Spain

This study aims to characterize the patient profiles and the clinical experience of iptacopan treatment in adult patients with C3G treated through an early access program (EAP) in Spain.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

35

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Novartis Pharmaceuticals

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Adult patients with a diagnosis of C3G who have received at least one dose of iptacopan through an EAP from 01 October 2020 through 30 June 2025.

Beschrijving

Inclusion criteria:

  1. Adult patients (≥18 years).
  2. Biopsy-confirmed C3G.
  3. Patients who have received at least one dose of iptacopan through an EAP from October 2020 to June 2025.

Exclusion criteria:

1. Patients treated with iptacopan through an EAP for indications other than C3G.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Iptacopan Cohort
Adult patients with C3G who received iptacopan through an EAP in Spain.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hoogte
Tijdsspanne: Basislijn
Basislijn
Gewicht
Tijdsspanne: Basislijn
Basislijn
Bloeddruk
Tijdsspanne: Baseline
Systolische en diastolische bloeddruk.
Baseline
Baseline Demografieën
Tijdsspanne: Baseline
Baseline
Number and Percentage of Patients by Clinical Characteristic
Tijdsspanne: Baseline

Clinical characteristics include:

  • Kidney status
  • History of dialysis
  • Presence of edema
  • Comorbidities
  • C3G histology subtype
  • Previous medication
  • Vaccination status
  • Receipt of antibiotic prophylaxis in addition to vaccination
  • History of severe infections
Baseline
Duration of Antibiotic Prophylaxis
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number of Hospitalizations due to Severe Infection Before Iptacopan Initiation
Tijdsspanne: Baseline
Baseline
Age at C3G Diagnosis
Tijdsspanne: Baseline
Baseline
Number and Percentage of Patients by Clinical Features at First C3G Diagnosis
Tijdsspanne: Baseline

Clinical features include:

  • Clinical presentation (nephrotic, nephritic, isolated non-nephrotic proteinuria, asymptomatic urinary abnormalities)
  • Presence of pathogenic variants in complement-related genes
  • Presence of autoantibodies against complement components
Baseline
Age at Last Kidney Transplantation Before Iptacopan Initiation
Tijdsspanne: Baseline
Baseline
Number of Kidney Transplants Before Iptacopan Initiation
Tijdsspanne: Baseline
Baseline
Number and Percentage of Patients by Clinical Features of Last Kidney Transplant Before Iptacopan Initiation
Tijdsspanne: Baseline

Clinical features include:

  • Previous recurrence with kidney failure
  • Kidney donor type
  • Highly sensitized (yes/no)
  • Immediate graft function
  • Type of induction therapy
  • Type of maintenance immunosuppressive (IS) therapy
  • Kidney transplant rejection episode and type of rejection
Baseline
Duration of Cold Ischemia for the Last Kidney Transplant Before Iptacopan Initiation
Tijdsspanne: Baseline
Baseline
Post-Kidney Transplant Estimated Glomerular Filtration Rate (eGFR)
Tijdsspanne: Baseline
Baseline
Number and Percentage of Patients by Type of Biopsy Performed to Confirm Recurrence of C3G After Kidney Transplant
Tijdsspanne: Baseline
Baseline
Duration Between Last Kidney Transplant and Biopsy Confirmed C3G Recurrence
Tijdsspanne: Baseline
Baseline
eGFR at Last Post-transplant C3G Recurrence
Tijdsspanne: Baseline
Baseline
Serum Albumin Concentration at Last Post-transplant C3G Recurrence
Tijdsspanne: Baseline
Baseline
Urine Protein-Creatine Ratio (UPCR) From First-Morning Void (FMV) at Last Post-transplant C3G Recurrence
Tijdsspanne: Baseline
Baseline
Proteinuria-24h at Last Post-transplant C3G Recurrence
Tijdsspanne: Baseline
Total protein excretion from 24-hour collection.
Baseline
Serum Complement Component 3 (C3) Concentration at Last Post-transplant C3G Recurrence
Tijdsspanne: Baseline
Baseline

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
UPCR FMV During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
UPCR-24h During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
UPCR from 24-hour collection.
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Proteinuria-24h During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Total protein excretion from 24-hour collection.
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Urine Albumin-to-Creatinine Ratio (UACR) FMV During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
UACR-24h During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
UACR from 24-hour collection.
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Albuminuria-24h During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Total albumin excretion from 24-hour collection.
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Serum Albumin Concentration During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Serum Creatinine Concentration During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
eGFR During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Difference Between Post- and Pre-Iptacopan Treatment eGFR Slopes
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients With Kidney Failure
Tijdsspanne: Months 3, 6, 9, 12, 18, 24, 30, and 36
Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients With a Kidney Transplant During Follow-up
Tijdsspanne: Months 3, 6, 9, 12, 18, 24, 30, and 36
Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients Who Initiate Dialysis During Follow-up
Tijdsspanne: Months 3, 6, 9, 12, 18, 24, 30, and 36
Months 3, 6, 9, 12, 18, 24, 30, and 36
Red Blood Cells (RBC) Count per High Power Field (HPF) During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Intensity of C3 Deposit in Direct Immunofluorescence (DIF) During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36

DIF intensity:

  • 0 (negative)
  • +1 (mild)
  • +2 (moderate)
  • +3 (strong)
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Type of Antibody Used for DIF at Each Biopsy During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Presence of Globally Sclerotic Glomeruli and Glomeruli With Crescents at Each Biopsy During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Percentage of Globally Sclerotic Glomeruli and Glomeruli With Crescents at Each Biopsy During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Degree of Interstitial Fibrosis/Tubular Atrophy (IF/TA) at Each Biopsy During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36

Degree of IF/TA categories:

  • None
  • Mild (<25%)
  • Moderate (25-50%)
  • Severe (>50%)
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Presence of Arteriosclerosis or Arteriolosclerosis at Each Biopsy During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Light Microscopy Pattern at Each Biopsy During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36

Light microscopy patterns:

  • Membranoproliferative glomerulonephritis (MPGN)
  • Diffuse endocapillary glomerulonephritis (GN)
  • Mesangial proliferative GN
  • Diffuse sclerosing GN
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Presence of Double Contours at Each Biopsy During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Presence of Leukocyte Infiltration at Each Biopsy During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Serum C3 Concentration During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Serum Complement Component 4 (C4) Concentration During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Serum Soluble Membrane Attach Complex (sC5b-9) Concentration During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Total Complement Function Assay (CH50) Concentration During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Daily Iptacopan Dose During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number of Missed or Delayed Doses During Iptacopan Treatment
Tijdsspanne: Months 3, 6, 9, 12, 18, 24, 30, and 36
Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients With Missed or Delayed Doses During Iptacopan Treatment
Tijdsspanne: Months 3, 6, 9, 12, 18, 24, 30, and 36
Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients Who Discontinued Iptacopan Treatment
Tijdsspanne: Months 3, 6, 9, 12, 18, 24, 30, and 36
Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Reason for Iptacopan Treatment Discontinuation
Tijdsspanne: Months 3, 6, 9, 12, 18, 24, 30, and 36
Months 3, 6, 9, 12, 18, 24, 30, and 36
Time to Iptacopan Treatment Discontinuation
Tijdsspanne: Months 3, 6, 9, 12, 18, 24, 30, and 36
Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Type of Concomitant Therapies
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Treatment Dose of Concomitant Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients on the Maximum Tolerated Dose of Concomitant Treatment: Renin-angiotensin System (RAS) Blockade
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients by Reason for Stopping Concomitant Treatment
Tijdsspanne: Months 3, 6, 9, 12, 18, 24, 30, and 36
Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients With Adverse Events of Special Interest (AESI)
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
AESIs include infections by encapsulated bacteria, thyroid abnormality, testicular abnormality, hypersensitivity reaction, malignancy, and thrombocytopenia.
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients With Severe AESI
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36

AESI include infections by encapsulated bacteria, thyroid abnormality, testicular abnormality, hypersensitivity reaction, malignancy, and thrombocytopenia.

Infections are categorized as severe if present with any of the following: fever with shivers/chills; headache with fever; fever with rash; fever with chest pain and cough; fever with breathlessness/fast breathing; fever with high heart rate; headache with nausea/vomiting; headache with stiff neck/back; confusion; body aches with flu-like symptoms; clammy skin; eyes sensitive to light.
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients Hospitalized due to an AESI
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
AESIs include infections by encapsulated bacteria, thyroid abnormality, testicular abnormality, hypersensitivity reaction, malignancy, and thrombocytopenia.
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Length of Stay in Hospital
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Number and Percentage of Patients who Die During Iptacopan Treatment
Tijdsspanne: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novartis Pharmaceuticals

Onderzoekers

  • Studie directeur: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

21 september 2026

Primaire voltooiing (Geschat)

15 december 2026

Studie voltooiing (Geschat)

15 december 2026

Studieregistratiedata

Eerst ingediend

14 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 mei 2026

Eerst geplaatst (Werkelijk)

20 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 september 2026

Laatste update ingediend die voldeed aan QC-criteria

16 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CLNP023B1ES01

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