AC/DC Study: Acidification test in patients with Chronic kidney Disease and healthy Controls

Completed

• Conditions: chronic kidney disease; chronic renal insufficiency; 10029149

• Registration Number: NL-OMON42898
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Patients with CKD:
- Male or female adults (*18 years)
- Chronic kidney disease stage 4 (eGFR: 15-30 ml/min/1.73 m2)
Healthy subjects:
- Healthy male or female adults (* 18 years)
- Normal kidney function (eGFR > 90 ml/min/1.73 m2)

Exclusion Criteria

Patients with CKD:
- Plasma bicarbonate level < 20.0 mmol/l
- Serum potassium >5.5 mmol/l
- Sodium bicarbonate use in the month preceding the study
- Heart failure (NYHA III or IV)
- Liver cirrhosis (Child Pugh B or C)
- Blood pressure >140/90 mmHg despite the use of 3 different anti-hypertensives
- Kidney transplantation
- Use of calcineurin inhibitors
- Known urea cycle disorder
- Alcoholism or drug use
- Pregnancy
- Current use of antibiotics, NSAIDS or alkalizing drugs (sodium-bicarbonate, citric acid, potassium citrate, acetazolamide)
- Inability to adhere to the study protocol (due to language barrier or intellectual disability);Healthy subjects:
- eGFR < 90 ml/min/1.73 m2
- plasma bicarbonate < 20 mmol/l.
- History of, or drugs for, diabetes mellitus
- History of chronic diarrheal disease
- Ileostomy/colostomy
- Known urea cycle disorder
- Alcoholism or drug use
- Pregnancy
- Current use of antibiotics, antihypertensive drugs, NSAIDS or alkalizing drugs
- Inability to adhere to the study protocol (due to language barrier or intellectual disability)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the change in urinary renin values (an accepted<br /><br>measure of intrarenal RAS activity).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>