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

NCT04363554 | Completed

• 1 other identifier: My-1-2017
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Kidney, Autosomal Dominant; Chronic Kidney Diseases

Keywords

CYSTS; KIDNEYS

Outcome Measures

Primary Outcomes (2)

• free water clearance CH20 u-osm

  free water clearance (CH2O)

  5 hours

• u-osm

  urine osmolality

  4 hours

Secondary Outcomes (1)

• free water clearance

  5 hours

Study Arms (2)

Urine dilution test

OTHER

Urine dilution test

Other: Fluid intake

Urine concentration test

OTHER

Urine concentration test

Other: Thirsting

Interventions

Fluid intake OTHER

The participants will intake fluid

Urine dilution test

Thirsting OTHER

The participants will thirst

Urine concentration test

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regional Hospital Holstebro: lead

Study Sites (1)

Department of Medical Research, Regional Hospital Holstebro

Holstebro, 7500, Denmark

Location

Related Publications (1)

• Malmberg MH, Mose FH, Pedersen EB, Bech JN. Urine concentration ability is reduced to the same degree in adult dominant polycystic kidney disease compared with other chronic kidney diseases in the same CKD-stage and lower THAN in healthy control subjects - a CASE control study. BMC Nephrol. 2020 Aug 31;21(1):379. doi: 10.1186/s12882-020-02043-w.

  PMID: 32867720 DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant; Renal Insufficiency, Chronic; Cysts

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms; Pathological Conditions, Anatomical

Study Officials

• My Malmberg, MD

  Departments of medical research and medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of University Clinic in Nephrology and Hypertension

Model Details: A case control, randomized crossover study

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: September 25, 2017
• Primary Completion: April 20, 2020
• Study Completion: April 20, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)