Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Renal plasma flow (RPF)
研究概览
简要总结
Polycystic kidney disease (ADPKD) is a common genetic disorder, characterized by the formation of cysts in the kidneys, causing gradual renal function-loss. Previous studies have shown that, reduced glomerular filtration rate (GFR) and renal plasma flow (RPF) play a role in the progression of renal disease in ADPKD. Tolvaptan is a vasopressin 2 antagonist, which seems to reduce the growth of total kidney volume (TKV) and the decline in e-GFR in ADPKD. The mechanism is not fully understood and could, at least partly, be caused by stimulation of the renal blood flow. The purpose of this trial is to investigate if tolvaptan´s improve renal blood flow and glomerular filtration in ADPKD, in a randomized, cross-over, double-blind, placebo-controlled study.
详细描述
The aim is to measure the acute effects of tolvaptan on:
- Renal hemodynamics (RPF, GFR, filtration fraction ((FF)) and renovascular resistance ((RVR))
- Blood pressure (central blood pressure ((cBP)) and brachial blood pressure bBP)
- Several vasoactive hormones (plasma renin ((PRC)), plasma angiotensin II ((p-Ang-II)), plasma aldosterone ((p-Aldo)), plasma vasopressin ((p-AVP))
in patients with ADPKD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Diagnosis with ADPKD
- •Informed consent
- •Contraception for fertile women
排除标准
- •Renal transplantation
- •Operation in the kidney
- •Diabetes mellitus
- •Neoplastic conditions
- •Pregnancy, nursing
- •Unwillingness to participate
- •eGFR > 30
- •Intolerance towards tolvaptan
- •Alcohol or medical abuse,
- •BP >>170/110 blood pressure despite regulation
研究组 & 干预措施
Tolvaptan
Drug: Tolvaptan
1 tablet before renography
干预措施: Tolvaptan (Drug)
Placebo
Placebo
1 tablet before renography
干预措施: Placebo (Drug)
结局指标
主要结局
Renal plasma flow (RPF)
时间窗: Two hours after trial medicine intake
Estimated by posterior Technetium-99m diethylenetriamine penta-acetic acid (99-mTc-DTPA) renography 2 hours after trial medicine intake. (unit of measurement= ml/min)
次要结局
- Urine output (OU)(Measured before and 3 hours after trial medicine intake)
- Central and brachial blood pressures (BP)(Measured every 15 minutes during the examination day)
- Plasma concentration of vasopressin (p-AVP)(Measured before and 3 hours after trial medicine intake)
- Filtration fraction (FF)(Two hours after trial medicine intake)
- Plasma concentration of renin (PRC)(Measured before and 3 hours after trial medicine intake)
- Plasma concentration of angiotensin II (p-AngII)(Measured before and 3 hours after trial medicine intake)
- Glomerular filtration rate (GFR)(Two hours after trial medicine intake)
- Plasma concentration of aldosterone (p-Aldo)(Measured before and 3 hours after trial medicine intake)
- Urine excretion of aquaporin 2 (u-AQP2)(Measured before and 3 hours after trial medicine intake)
- Urine osmolality (U-osm)(measured before and 3 hours after trial medicine intake)
- Albumin excretion rate(Measured before and 3 hours after trial medicine intake)
- Fractional excretion of sodium (FENa)(Measured before and 3 hours after trial medicine intake)
研究者
Erling Bjerregaard Pedersen
Professor
Regional Hospital Holstebro