AC/DC Study: Acidification Test in Patients With Chronic Kidney Disease and Healthy Controls (AC/DC)
Primary Purpose
Chronic Kidney Disease stage4
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Urinary acidification test
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Kidney Disease stage4
Eligibility Criteria
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)
Sites / Locations
- Erasmus MC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with chronic kidney disease
Healthy controls
Arm Description
Outcomes
Primary Outcome Measures
Urinary renin
Secondary Outcome Measures
Full Information
NCT ID
NCT03293446
First Posted
September 20, 2017
Last Updated
June 19, 2019
Sponsor
Erasmus Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03293446
Brief Title
AC/DC Study: Acidification Test in Patients With Chronic Kidney Disease and Healthy Controls
Acronym
AC/DC
Official Title
AC/DC Study: Acidification Test in Patients With Chronic Kidney Disease and Healthy Controls
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 7, 2016 (Actual)
Primary Completion Date
November 11, 2018 (Actual)
Study Completion Date
November 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease stage4
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with chronic kidney disease
Arm Type
Experimental
Arm Title
Healthy controls
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Urinary acidification test
Intervention Description
Urinary acidification by administration of ammonium chloride (100 mg/kg body weight, given orally) during a single-day hospital admission.
Primary Outcome Measure Information:
Title
Urinary renin
Time Frame
up to 6 hours
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
only males
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015CN
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
AC/DC Study: Acidification Test in Patients With Chronic Kidney Disease and Healthy Controls
We'll reach out to this number within 24 hrs