AC/DC Study: Acidification Test in Patients With Chronic Kidney Disease and Healthy Controls

Chronic Kidney Disease stage4 Clinical Trial

— AC/DC  

Official title:

AC/DC Study: Acidification Test in Patients With Chronic Kidney Disease and Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293446
• Other study ID #: NL57148.078.16
• Status: Completed
• Phase: N/A
• Start date: October 7, 2016
• Est. completion date: November 11, 2018

Study information

• Verified date: June 2019
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study the effect of an acute acid load on the intrarenal renin angiotensin-system is evaluated in patients with chronic kidney disease and healthy controls

Description:

Metabolic acidosis is one of the metabolic complications of chronic kidney disease (CKD). Correction of metabolic acidosis in CKD has been shown to prevent further loss of kidney function over time. Currently, a clinical trial (the BIC-study, MEC-2013-332) is conducted in which patients with CKD and metabolic acidosis receive sodium bicarbonate, sodium chloride, or no treatment (time control) to address the hypothesis that the beneficial effects of acidosis correction are mediated through inhibition of the intrarenal renin-angiotensin system (RAS). It is unknown, however, if and how acute changes in acid-base status affect the intrarenal RAS during CKD. In the present study it is hypothesized that an acute acid load increases the activity of the intrarenal RAS, and that this response is exaggerated in patients with CKD compared with healthy controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 11, 2018
• Est. primary completion date: November 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

Patients with CKD:

• Male or female adults (=18 years)

• Chronic kidney disease stage 4 (eGFR: 15-30 ml/min/1.73 m2, calculated using the CKD-EPI equation)

Healthy controls:

• Healthy male or female adults (= 18 years)

• Normal kidney function (eGFR > 90 ml/min/1.73 m2, calculated using the CKD-EPI equation)

Exclusion Criteria:

• CKD patients

• Plasma bicarbonate level < 20.0 mmol/l

• Serum potassium >5.5 mmol/l

• Sodium bicarbonate use in the month preceding the test

• 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-hypertensive drugs

• Kidney transplantation

• Use of calcineurin inhibitors (these immunosuppressive drugs affect acid-base balance)

• 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 controls:

• eGFR < 90 ml/min/1.73 m2 (calculated using the CKD-EPI equation)

• 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 (sodium-bicarbonate, citric acid, potassium citrate, acetazolamide)

• Inability to adhere to the study protocol (due to language barrier or intellectual disability)

Related Conditions & MeSH terms

• Chronic Kidney Disease stage4
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• Urinary acidification test
Urinary acidification by administration of ammonium chloride (100 mg/kg body weight, given orally) during a single-day hospital admission.

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary renin		up to 6 hours