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CompletedNCT03293446AC/DCUpdated Jun 20, 2019

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

An interventional study of Urinary acidification test in Chronic Kidney Disease stage4, sponsored by Erasmus Medical Center. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-20.

Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
Male
01

Study 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

Read the 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.

02

Conditions studied

  • Chronic Kidney Disease stage4
03

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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)
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Patients with chronic kidney disease

    Diagnostic Test: Urinary acidification test

  • Active comparator
    Healthy controls

    Diagnostic Test: Urinary acidification test

Interventions

  • Diagnostic testUrinary acidification test

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

05

What researchers measure

Primary outcomes

  1. Urinary renin

    Time frame: up to 6 hours

06

Study locations

1 site
  • Erasmus MC
    Rotterdam, Zuid-Holland 3015CN, Netherlands
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03293446
Lead sponsor
Erasmus Medical Center
Responsible party
Ewout Hoorn (doctor, Erasmus Medical Center) — Principal investigator
First posted
Sep 26, 2017
Start date
Oct 7, 2016
Primary completion
Nov 11, 2018
Completion
Nov 11, 2018
Last update
Jun 20, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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