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

14 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Tipo di studio

Osservativo

Iscrizione (Stimato)

35

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Novartis Pharmaceuticals

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Altezza
Lasso di tempo: Linea di base
Linea di base
Il peso
Lasso di tempo: Linea di base
Linea di base
Pressione Sanguigna
Lasso di tempo: Baseline
Pressione sistolica e diastolica.
Baseline
Dati demografici al basale
Lasso di tempo: Valore basale
Valore basale
Number and Percentage of Patients by Clinical Characteristic
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
Baseline
Age at C3G Diagnosis
Lasso di tempo: Baseline
Baseline
Number and Percentage of Patients by Clinical Features at First C3G Diagnosis
Lasso di tempo: 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
Lasso di tempo: Baseline
Baseline
Number of Kidney Transplants Before Iptacopan Initiation
Lasso di tempo: Baseline
Baseline
Number and Percentage of Patients by Clinical Features of Last Kidney Transplant Before Iptacopan Initiation
Lasso di tempo: 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
Lasso di tempo: Baseline
Baseline
Post-Kidney Transplant Estimated Glomerular Filtration Rate (eGFR)
Lasso di tempo: Baseline
Baseline
Number and Percentage of Patients by Type of Biopsy Performed to Confirm Recurrence of C3G After Kidney Transplant
Lasso di tempo: Baseline
Baseline
Duration Between Last Kidney Transplant and Biopsy Confirmed C3G Recurrence
Lasso di tempo: Baseline
Baseline
eGFR at Last Post-transplant C3G Recurrence
Lasso di tempo: Baseline
Baseline
Serum Albumin Concentration at Last Post-transplant C3G Recurrence
Lasso di tempo: Baseline
Baseline
Urine Protein-Creatine Ratio (UPCR) From First-Morning Void (FMV) at Last Post-transplant C3G Recurrence
Lasso di tempo: Baseline
Baseline
Proteinuria-24h at Last Post-transplant C3G Recurrence
Lasso di tempo: Baseline
Total protein excretion from 24-hour collection.
Baseline
Serum Complement Component 3 (C3) Concentration at Last Post-transplant C3G Recurrence
Lasso di tempo: Baseline
Baseline

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
UPCR FMV During Iptacopan Treatment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novartis Pharmaceuticals

Investigatori

  • Direttore dello studio: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

16 maggio 2026

Completamento primario (Stimato)

30 settembre 2026

Completamento dello studio (Stimato)

30 settembre 2026

Date di iscrizione allo studio

Primo inviato

14 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 maggio 2026

Primo Inserito (Effettivo)

20 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CLNP023B1ES01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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