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临床试验/NCT04310319
NCT04310319Unknown不适用

Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt

Esther Meijer2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年9月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
12
试验地点
2
主要终点
24-hour urine volume

研究概览

简要总结

This study evaluates the effect of regulating salt and protein intake on urinevolume in patients with ADPKD treated with a vasopressine V2 receptor antagonist (V2RA). The investigators hypothesize that changing sodium and protein intake will reduce V2RA-induced polyuria.

详细描述

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is characterized by the formation of numerous cysts in both kidneys and progressive renal function decline leading to renal replacement therapy (RRT) at a median age of 58 years. The first (and at the moment only) drug to slow down renal function decline, is a vasopressin V2 receptor antagonist (V2RA). This medicament slows renal function decline by 26 to 34%. V2RA also causes aquaresis associated side-effects such as polyuria of >6 liter per day in the majority of patients. These side-effects limit wide spread use among ADPKD-patients. Therefore, there is a need to improve its tolerability. While using a V2RA, urine concentrating ability is strongly diminished. Therefore, urine volume is largely determined by total osmolar excretion. This is a well-known fact in nephrogenic diabetes insipidus, a disease with clear pathophysiological similarities to treatment with a vasopressin V2 receptor antagonist (a defect receptor versus pharmacological blockade). A recent study found osmolar excretion to be associated with urinary volume during V2RA treatment. Whether a change in osmolar load changes polyuria during V2RA has not yet been investigated. The investigators hypothesize that changing sodium and protein intake will reduce polyuria.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

24-hour urine volume

时间窗: Baseline, week 2, week 4, week 6, week 8.

Change in 24-hour urine volume as percentage, comparing the mean of the volumes collected during baseline with the mean of the two volumes collected at the end of each treatment period.

次要结局

  • Serum copeptin levels(Baseline, week 2, week 4, week 6, week 8.)
  • mGFR(Baseline, week 2, week 4, week 6, week 8.)
  • Blood pressure(Baseline, week 2, week 4, week 6, week 8.)
  • Quality of life, assesed by using the ADPKD-IS questionnaire.(Baseline, week 2, week 4, week 6, week 8.)
  • Quality of life, assesed by using the NADIQ-questionnaire.(Baseline, week 2, week 4, week 6, week 8.)

研究者

发起方
Esther Meijer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Esther Meijer

Principal Investigator, nephrologist

University Medical Center Groningen

研究点 (2)

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