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

28 августа 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Тип исследования

Наблюдательный

Регистрация (Оцененный)

35

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Novartis Pharmaceuticals
  • Номер телефона: +41613241111
  • Электронная почта: novartis.email@novartis.com

Учебное резервное копирование контактов

  • Имя: Novartis Pharmaceuticals

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Высота
Временное ограничение: Базовый уровень
Базовый уровень
Масса
Временное ограничение: Базовый уровень
Базовый уровень
Артериальное давление
Временное ограничение: Исходный уровень
Систолическое и диастолическое артериальное давление.
Исходный уровень
Исходные демографические данные
Временное ограничение: [[[Исходный уровень]]]
[[[Исходный уровень]]]
Number and Percentage of Patients by Clinical Characteristic
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline
Baseline
Age at C3G Diagnosis
Временное ограничение: Baseline
Baseline
Number and Percentage of Patients by Clinical Features at First C3G Diagnosis
Временное ограничение: 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
Временное ограничение: Baseline
Baseline
Number of Kidney Transplants Before Iptacopan Initiation
Временное ограничение: Baseline
Baseline
Number and Percentage of Patients by Clinical Features of Last Kidney Transplant Before Iptacopan Initiation
Временное ограничение: 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
Временное ограничение: Baseline
Baseline
Post-Kidney Transplant Estimated Glomerular Filtration Rate (eGFR)
Временное ограничение: Baseline
Baseline
Number and Percentage of Patients by Type of Biopsy Performed to Confirm Recurrence of C3G After Kidney Transplant
Временное ограничение: Baseline
Baseline
Duration Between Last Kidney Transplant and Biopsy Confirmed C3G Recurrence
Временное ограничение: Baseline
Baseline
eGFR at Last Post-transplant C3G Recurrence
Временное ограничение: Baseline
Baseline
Serum Albumin Concentration at Last Post-transplant C3G Recurrence
Временное ограничение: Baseline
Baseline
Urine Protein-Creatine Ratio (UPCR) From First-Morning Void (FMV) at Last Post-transplant C3G Recurrence
Временное ограничение: Baseline
Baseline
Proteinuria-24h at Last Post-transplant C3G Recurrence
Временное ограничение: Baseline
Total protein excretion from 24-hour collection.
Baseline
Serum Complement Component 3 (C3) Concentration at Last Post-transplant C3G Recurrence
Временное ограничение: Baseline
Baseline

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
UPCR FMV During Iptacopan Treatment
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36
Baseline, Months 3, 6, 9, 12, 18, 24, 30, and 36

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Novartis Pharmaceuticals

Следователи

  • Директор по исследованиям: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

10 сентября 2026 г.

Первичное завершение (Оцененный)

15 декабря 2026 г.

Завершение исследования (Оцененный)

15 декабря 2026 г.

Даты регистрации исследования

Первый отправленный

14 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

14 мая 2026 г.

Первый опубликованный (Действительный)

20 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

31 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

28 августа 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • CLNP023B1ES01

Планирование данных отдельных участников (IPD)

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НЕТ

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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