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Идёт набор NCT07511283

Calciphylaxis in Patients With Chronic Kidney Disease - A Study of the Danish Calciphylaxis Research Initiative (DanCaRI)

— Наблюдательное Calciphylaxis Calcific Uremic Arteriolopathy End Stage Renal Disease (ESRD) Chronic Kidney Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Calciphylaxis, Calcific Uremic Arteriolopathy, End Stage Renal Disease (ESRD), Chronic Kidney Diseases. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Calciphylaxis is a rare yet life-threatening condition involving pronounced calcification in small blood vessels of the skin. Knowledge about its underlying mechanisms and contributing risk factors remains limited. Chronic kidney disease is one of the strongest disease predictors. No evidence based effective therapy is currently available. Research on the topic is mainly hindered by the condition's rarity. The study Calciphylaxis in patients with chronic kidney disease - A study of the Danish Calciphylaxis Research Initiative (DanCaRI) is set up to facilitate the systematic retrospective and prospective comparison of patients with chronic kidney disease and calciphylaxis to matched patients with chronic kidney disease who did not develop calciphylaxis thereby providing new knowledge that can support prevention, early detection, and new treatment approaches.

Подробное описание

Calciphylaxis is a rare yet life-threatening condition involving pronounced calcification in small blood vessels of the skin.

Knowledge about its underlying mechanisms and contributing risk factors remains limited. Chronic kidney disease is one of the strongest disease predictors. No evidence based effective therapy is currently available. Research on the topic is mainly hindered by the condition's rarity.

The study Calciphylaxis in patients with chronic kidney disease - A study of the Danish Calciphylaxis Research Initiative (DanCaRI) is set up to facilitate the systematic retrospective (two years) and prospective (three years follow-up period) comparison of patients with chronic kidney disease and calciphylaxis (cases) to matched patients with chronic kidney disease who did not develop calciphylaxis (controls) thereby providing new knowledge that can support prevention, early detection, and new treatment approaches.

The study collects clinical data and biological samples. A healthy group is part of the study to enable comparison to reference parameters.

Первичные конечные точки

  • All-cause mortality [Срок оценки: 3 year follow up period]
Вторичные конечные точки (4)
  • Pain severity [Срок оценки: 3 year follow up period]
  • Quality of life (QoL) [Срок оценки: 3 year follow up period]
  • Hospitalizations [Срок оценки: 3 year follow up period]
  • Calciphylaxis Wound Status [Срок оценки: 3 year follow up period]

Критерии участия

Критерии включения

Cases

  • Age ≥18 years.
  • CKD.
  • Suspicion of calciphylaxis or newly diagnosed calciphylaxis episode. The suspicion or diagnosis of calciphylaxis is a mutual decision of the involved medical specialties (nephrologist, dermatologist, pathologist, other).
  • Ability to give informed consent.
  • Ability to participate in a clinical study as assessed by the local investigator.
  • Provides written informed consent.

Controls

  • Age ≥18 years.
  • CKD
  • Ability to give informed consent.
  • Ability to participate in a clinical study as assessed by the local investigator.
  • Provides written informed consent.

Healthy reference group

  • Age ≥18 years.
  • Self-assessed as healthy, confirmed by local investigators at inclusion

Критерии исключения

Cases

\- the calciphylaxis diagnosis becomes excluded

Controls - Being diagnosed with calciphylaxis

Healthy controls Up to 60 years of age: eGFR below 60 ml/min/1.72m2.

\- Over 60 years of age: eGFR below the 95% confidence interval for eGFR adjusted for age (Danish Society of Nephrology references ranges)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Дания · 1 центр
  • Odense University Hospital — Odense

Идентификаторы

NCT: NCT07511283 · S-20250043

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗