The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease

Chronic Kidney Diseases Clinical Trial

— POVA  

Official title:

The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) or Other Cause of Chronic Renal Disease Compared to Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363554
• Other study ID #: My-1-2017
• Status: Completed
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: April 20, 2020

Study information

• Verified date: April 2020
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ability to concentrate and dilute urine is primarily regulated via vasopressin (AVP) dependent Aquaporin-2 water channels (AQP2 channels) in the kidney's collecting duct. Autosomal dominant polycystic kidney disease (ADPKD) is a common genetic disorder, characterized by the formation of cyst in the kidneys, causing gradual renal function-loss. Previous studies indicate that ADPKD patients have decreased urine concentration, higher plasma osmolality, and plasma AVP levels compared to healthy controls. Previous studies also indicate that ADPKD patients' dysregulated AVP is an important factor for the pathogenesis and progression of the disease. It is unclear whether ADPKD patients' ability to concentrate and dilute urine are different from those of other cause of chronic renal disease to the same degree. It is also unclear, what mechanisms cause the decreased ability to concentrate and dilute urine in chronic renal disease patients. The purpose of this trial is to investigate the difference in renal function during concentration and dilution test in a case-control, randomized, cross-examination study with ADKPD patients or other cause of chronic renal disease compared to healthy volunteers.

Description:

The aim is to measure the difference in renal function, including kidney tubular function, blood pressure and vasoactive hormones in patients with Autosomal dominant polycystic kidney disease (ADPKD) or other chronic renal disease compared to healthy volunteers, during concentration and dilution test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 20, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ADPKD patients: -age >18 years, diagnosis with ADPKD, informed consent, contraception for fertile women

• Patients with chronic kidney disease: age >18 years, diagnosis with chronic kidney disease other then ADPKD, informed consent, contraception for fertile women

• Healthy volunteers: age >18 years, healthy, informed consent, contraception for fertile women

Exclusion Criteria:

• ADPKD patients: Renal transplantation, operation in the kidney, Diabetes mellitus, neoplastic conditions, pregnancy, breastfeeding, unwillingness to participate, intolerance towards urine dilution or urine concentration test, alcohol or medical abuse, BP >170/110 despite regulation, unacceptable side effects to background medication (antihypertensive medicine) during the trial.

• Patients with chronic kidney disease: Renal transplantation, operation in the kidney, Diabetes mellitus, medullary cystic kidney disease, lithium nephropathy, neoplastic conditions, pregnancy, nursing, unwillingness to participate, intolerance towards urine dilution or urine concentration test, alcohol or medical abuse, BP >170/110 despite regulation, unacceptable side effects to background medication (antihypertensive medicine) during the trial.

• Healthy volunteers: Arterial hypertension, significant clinical signs of heart, lungs, liver, kidneys, endocrine, brain or neoplastic disorders, alcohol or drug abuse, medical treatment, smoking, pregnancy or breastfeeding, smoking, clinically significant abnormal findings in blood, urine tests or electrocardiogram, blood donation within the last month before the examination date in the first trial sequence, intolerance to or unacceptable side effects of urine concentration and urine dilution test

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant
• Renal Insufficiency, Chronic

Intervention

Other:
• Fluid intake
The participants will intake fluid
• Thirsting
The participants will thirst

Locations

Country	Name	City	State
Denmark	Department of Medical Research, Regional Hospital Holstebro	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	free water clearance CH20 u-osm	free water clearance (CH2O)	5 hours
Primary	u-osm	urine osmolality	4 hours
Secondary	free water clearance	free water clearance (CH2O)	5 hours