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

2026년 5월 14일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

연구 유형

관찰

등록 (추정된)

35

연락처 및 위치

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연구 연락처

연구 연락처 백업

  • 이름: Novartis Pharmaceuticals

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

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  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
키
기간: 기준선
기준선
무게
기간: 기준선
기준선
혈압
기간: 기준선
수축기 및 이완기 혈압.
기준선
기준 인구 통계
기간: 기준선
기준선
Number and Percentage of Patients by Clinical Characteristic
기간: 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
기간: 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
기간: Baseline
Baseline
Age at C3G Diagnosis
기간: Baseline
Baseline
Number and Percentage of Patients by Clinical Features at First C3G Diagnosis
기간: 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
기간: Baseline
Baseline
Number of Kidney Transplants Before Iptacopan Initiation
기간: Baseline
Baseline
Number and Percentage of Patients by Clinical Features of Last Kidney Transplant Before Iptacopan Initiation
기간: 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
기간: Baseline
Baseline
Post-Kidney Transplant Estimated Glomerular Filtration Rate (eGFR)
기간: Baseline
Baseline
Number and Percentage of Patients by Type of Biopsy Performed to Confirm Recurrence of C3G After Kidney Transplant
기간: Baseline
Baseline
Duration Between Last Kidney Transplant and Biopsy Confirmed C3G Recurrence
기간: Baseline
Baseline
eGFR at Last Post-transplant C3G Recurrence
기간: Baseline
Baseline
Serum Albumin Concentration at Last Post-transplant C3G Recurrence
기간: Baseline
Baseline
Urine Protein-Creatine Ratio (UPCR) From First-Morning Void (FMV) at Last Post-transplant C3G Recurrence
기간: Baseline
Baseline
Proteinuria-24h at Last Post-transplant C3G Recurrence
기간: Baseline
Total protein excretion from 24-hour collection.
Baseline
Serum Complement Component 3 (C3) Concentration at Last Post-transplant C3G Recurrence
기간: Baseline
Baseline

2차 결과 측정

결과 측정
측정값 설명
기간
UPCR FMV During Iptacopan Treatment
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

수사관

  • 연구 책임자: Novartis Pharmaceuticals, Novartis Pharmaceuticals

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 16일

기본 완료 (추정된)

2026년 9월 30일

연구 완료 (추정된)

2026년 9월 30일

연구 등록 날짜

최초 제출

2026년 5월 14일

QC 기준을 충족하는 최초 제출

2026년 5월 14일

처음 게시됨 (실제)

2026년 5월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 14일

마지막으로 확인됨

2026년 5월 1일

추가 정보

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추가 관련 MeSH 약관

기타 연구 ID 번호

  • CLNP023B1ES01

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