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Идёт набор NCT07368712

A Methodological Study to Learn More About Kidney Function in Healthy People and in People With Reduced Kidney Function

Без фазы С лечением Acute Kidney Injury, Renal Insufficiency

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
В протоколе указаны: No investigational study intervention.
Кому может быть актуально
Состояния в реестре: Acute Kidney Injury, Renal Insufficiency. Базовые параметры: 18 лет — 75 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
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Study to Investigate Renal Functional Reserve in Healthy Participants and in Participants With Impaired Renal Function.

Обзор

The main purpose of this study is to investigate how reliable a test assessing the renal functional reserve (RFR) and the maximum glomerular filtration rate (maxGFR) are. MaxGFR and RFR assessments are repeated twice at 1-month intervals. If precise, this test may improve the measure of kidney function and be useful in future studies for people with chronic kidney problems. To do this, the researchers will collect and analyze information about kidney function from up to 50 adults, including healthy people and people with stable kidney problems. Each person will come to the study center for a screening visit and then three study days, each about a month apart. On each study day, participants will have blood and urine samples taken before and after drinking a protein shake. The tests will measure things like creatinine, cystatin C, and other markers in the blood and urine to see how the kidneys are working. The study will also record basic health information, weight, blood pressure, and any medicines being taken. The study will last about 2 to 2.5 months for each participant.

Вмешательства

  • Другое No investigational study intervention
    The study does not involve the administration of any study intervention, investigational medicinal product, or device. Participants will undergo blood collection and urine sampling both before and after consuming a high-protein meal.

Первичные конечные точки

  • Maximun kidneyfunction determined by measurement of creatinine clearance (mGFRCR) [Срок оценки: Day 1, 28 and 56]
  • Renal functional reserve by measurement of creatinine clearance (mGFRCR) [Срок оценки: Day 1, 28 and 56]
Вторичные конечные точки (4)
  • Maximum kidney function and renal functional reserve derived from serum creatinine-based eGFR (eGFRSCR) [Срок оценки: Day 1, 28 and 56]
  • Maximum kidney function and renal functional reserve derived from serum cystatin C-based eGFR (eGFRCYS) [Срок оценки: Day 1, 28 and 56]
  • Maximum kidney function and renal functional reserve derived from serum creatinine-based and serum cystatin C-based eGFR (eGFRSCR-CYS) [Срок оценки: Day 1, 28 and 56]
  • Maximum creatinine clearance and renal functional reserve derived from plasma PENK-based eGFR (eGFRPENK) [Срок оценки: Day 1, 28 and 56]

Критерии участия

Критерии включения

  • Participant must be 18 to 75 years of age inclusive, at the time of signing the ICF.
  • Stable medical condition defined as no new drug or other treatment prescribed for a chronic condition within 60 days prior to Study Day 1.
  • Body weight between 50 and 100 kg.
  • Female Participants: A participant is eligible to participate if not pregnant or breastfeeding. If a urine test cannot be confirmed as negative at screening (e.g., an ambiguous result), the participant must be excluded from participation.

Критерии исключения

  • Recent surgical intervention within 60 days prior to Study Day 1.
  • New clinical diagnosis established within 60 days prior to Study Day 1.
  • New drug prescription within 60 days prior to Study Day 1.
  • Relevant change in severity of any medical condition within 60 days prior to Study Day 1, e.g. disease flare.
  • Known congenital amino acid metabolism disorders.
  • Severe hypersensitivity to milk products.
  • Known liver cirrhosis.
  • Regular use of non-steroidal anti-inflammatory drugs (NSAIDs).
  • Impaired kidney function with eGFR <30 mL/min/1.73m2

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Германия · 1 центр
  • Bayer AG - Occupational Health Services — Berlin

Идентификаторы

NCT: NCT07368712 · 23125

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗