MR-Progression-Evaluation of Chronic Kidney Disease

• Conditions: Q61.2; N18; Polycystic kidney, autosomal dominant; Chronic kidney disease

• Registration Number: DRKS00015866
• Lead Sponsor: Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-05
• Study Completion: 2024-06-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

healthy subjects: 18-39 years of age, Body Mass Index (BMI) between 17-30kg/m² and Cockcroft-Gault or MDRD estimate of creatinine clearance >70mL/min (based on medical reports not older than two years; otherwise blood will be drawn for a new evaluation).

ADPKD subjects: 18-39 years of age, diagnosis ADPKD (type I or II) based on a positive family history and/or at least three kidney cysts (unilateral or bilateral), BMI between 17-30kg/m², Cockcroft-Gault or MDRD estimate of creatinine clearance >70mL/min (based on medical reports not older than two years; otherwise blood will be drawn), no albuminuria, and total cystic volume under 350mL and 450mL for women and men, respectively. Participants with a disputable ADPKD diagnosis or unmeasured kidney and cysts dimensions will be able to undergo an MRI evaluation, in order to prevent subjects to undergo an unnecessary renal function scintigraphy test.

Exclusion Criteria

healthy subjects: pregnancy, breast feeding, mean seated blood pressure above 145/95mmHg and seated heart rate above 100 beats per second, diabetes mellitus (fasting glucose >126mg/dl, treatment with insulin or oral hypoglycemics), known atrial fibrillation or atrioventricular block grade II or higher, history of myocardial infarction, unstable angina pectoris, evident congestive heart failure (New York Heart Association class III/IV), established renal impairment or chronic disease potentially affecting renal function, and intake of antihypertensive medication, nonsteroidal antiinflammatory drugs like acetylsalicylic acid or diuretics, implants, which are not safe for 3T.

ADPKD subjects: pregnancy, breast feeding, mean seated blood pressure above 160/100mmHg and seated heart rate above 100 beats per minute, diabetes mellitus (fasting glucose >126mg/dl, treatment with insulin or oral hypoglycemics), known atrial fibrillation or atrioventricular block grade II or higher, history of myocardial infarction, unstable angina pectoris, evident congestive heart failure (New York Heart Association class III/IV), established moderate renal impairment (GFR category G3a or higher and albuminuria category A2 or higher) or other systemic diseases potentially affecting renal function, intake of nonsteroidal antiinflammatory drugs like acetylsalicylic acid or diuretics, and previous renal surgery or cyst drainage procedures, implants, which are not safe for 3T..

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reproducibility and alteration of quantitative T1 relaxation time, apparent diffusion constant, fractional anisotropy, and Stiffness due to fluid intake (z.B. Wasser, Fruchtsäfte) on healthy and ADPKD subjects. <br>

Secondary Outcome Measures

Name	Time	Method
Alterations and Correlations during the course of the ADPKD.