Diuretic Testing in Chronic Kidney Disease

Обзор

The goal of this clinical trial is to predict the progression of chronic kidney disease by diuretic testing in patients with chronic kidney disease. The main questions it aims to answer are: Does a worse result of a diuretic test predict the progression of chronic kidney disease? If there is a comparison group: Researchers will compare the diuretic test in patients with chronic kidney disease to healthy participants to see if the results are different in a healthy kidney. Participants will undergo diuretic testing. This involves the administration of bumetanide and hydrochlorothiazide with subsequent blood and urine collections.

Вмешательства

• Диагностический тест Diuretic Testing
  The administration of hydrochlorothiazide and bumetanide is used to stimulate and assess tubular function.

Первичные конечные точки

• Progression of Chronic Kidney Disease [Срок оценки: 3 years]

Критерии участия

Inclusion Criteria for CKD subjects:

• CKD stage G3 (creatinine-based eGFR 30-59 mL/min/1.73m2) during the last outpatient visit

Inclusion Criteria for Healthy subjects:

• eGFR within the expected range for age (a decline of 1 ml/min/1.73 m2 per year starting from age 40 is considered the normal age-related decline in kidney function

Критерии исключения

• Known intolerance or allergy to the diuretics
• Current systemic chemotherapy for malignancy
• Kidney transplant recipient
• Use of calcineurin-inhibitors
• Life expectancy < 12 months
• Current immunosuppressive treatment for glomerulonephritis
• Incapacitated subjects or subjects who are deemed unfit to adequately adhere to instructions from the research team
• Hypokalemia or hyperkalemia (K+ < 3.0mmol/L or K+ > 5.5 mmol/L) at inclusion visit
• Hypo- or hypernatremia (Na+ < 130 mmol/L or Na+ > 150mmol/L) at inclusion visit
• Inherited tubulopathy as the cause of CKD
• Autosomal dominant polycystic or tubulointerstitial kidney disease causing CKD
• Clinically relevant heart failure (New York Heart Association class III or IV)
• Therapy-resistant hypertension, defined as systolic blood pressure > 180mmHg at the inclusion visit
• Current treatment with inhibitors of Organic anion transporters: probenecid, pravastatin, cimetidine, cephalosporins, acetazolamide \[22\]
• Active hepatitis during last outpatient visit
• Liver cirrhosis in advanced stage (Child-Pugh B or C)
• Active drug- or alcohol abuse
• Not being able to tolerate a 28-day washout of one of the drugs interfering with diuretic testing.
• Women who are pregnant, breastfeeding, or planning on becoming pregnant before the test day

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Нидерланды · 1 центр

• Erasmus MC — Rotterdam

Публикации

• Colussi G, Bettinelli A, Tedeschi S, De Ferrari ME, Syren ML, Borsa N, Mattiello C, Casari G, Bianchetti MG. A thiazide test for the diagnosis of renal tubular hypokalemic disorders. Clin J Am Soc Nephrol. 2007 May;2(3):454-60. doi: 10.2215/CJN.02950906. Epub 2007 Mar 14. PMID 17699451
• Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Shaw AD, Tumlin JA, Trevino SA, Kimmel PL, Seneff MG. Development and standardization of a furosemide stress test to predict the severity of acute kidney injury. Crit Care. 2013 Sep 20;17(5):R207. doi: 10.1186/cc13015. PMID 24053972
• Rodriguez-Iturbe B, Herrera J, Marin C, Manalich R. Tubular stress test detects subclinical reduction in renal functioning mass. Kidney Int. 2001 Mar;59(3):1094-102. doi: 10.1046/j.1523-1755.2001.0590031094.x. PMID 11231365

Идентификаторы

NCT: NCT06841692 · MEC-2024-0799 · 101125504 · NL-005327 · NL87576.078.24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗