Chronic Kidney Disease stage4AC/DCNCT03293446
AC/DC Study: Acidification Test in Patients With Chronic Kidney Disease and Healthy Controls
A study testing Urinary acidification test in people with Chronic Kidney Disease stage4, run by Erasmus Medical Center at 1 site in Netherlands.
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 Read more about this study
- Who is it for?
- Ages 18 to 99 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease stage4
- What is being tested?
- Urinary acidification test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Oct 2016to 11 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Show all 25Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chronic Kidney Disease stage4
- Being tested
- Urinary acidification test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary acidification testDiagnostic test
Urinary acidification by administration of ammonium chloride (100 mg/kg body weight, given orally) during a single-day hospital admission.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic kidney disease | Experimental | Not described Receives: Diagnostic Test: Urinary acidification test |
| Healthy controls | Active comparator | Not described Receives: Diagnostic Test: Urinary acidification test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary renin
Measured: up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start7 Oct 2016
- Primary completion11 Nov 2018
- Study completion11 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease stage4Studies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ewout Hoorn, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293446
- Sponsor's protocol ID
- NL57148.078.16
- Acronym
- AC/DC
- Status last verified
- Jun 2019
- First submitted
- 20 Sep 2017
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AC/DC Study: Acidification Test in Patients With Chronic Kidney Disease and Healthy Controls
- ClinicalTrials.gov ID
- NCT03293446
- Acronym / sponsor ID
- AC/DC / NL57148.078.16
- Conditions
- Chronic Kidney Disease stage4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 7 Oct 2016 (actual)
- Primary completion
- 11 Nov 2018 (actual)
- Study completion
- 11 Nov 2018 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic kidney disease | Experimental | Diagnostic Test: Urinary acidification test |
| Healthy controls | Active comparator | Diagnostic Test: Urinary acidification test |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary acidification testUrinary acidification by administration of ammonium chloride (100 mg/kg body weight, given orally) during a single-day hospital admission. | Diagnostic test | Healthy controls, Patients with chronic kidney disease |
Primary outcome
Urinary renin
Time frame: up to 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary acidification test in people with Chronic Kidney Disease stage4, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary renin (time frame: up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.