NCT03293446

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2018

Completed
Last Updated

June 20, 2019

Status Verified

June 1, 2019

Enrollment Period

2.1 years

First QC Date

September 20, 2017

Last Update Submit

June 19, 2019

Conditions

Chronic Kidney Disease stage4

Outcome Measures

Primary Outcomes (1)

  • Urinary renin

    up to 6 hours

Study Arms (2)

Patients with chronic kidney disease

EXPERIMENTAL
Diagnostic Test: Urinary acidification test

Healthy controls

ACTIVE COMPARATOR
Diagnostic Test: Urinary acidification test

Interventions

Urinary acidification testDIAGNOSTIC_TEST

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

Healthy controlsPatients with chronic kidney disease

Eligibility Criteria

Age18 Years - 99 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsonly males
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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:
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015CN, Netherlands

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 26, 2017

Study Start

October 7, 2016

Primary Completion

November 11, 2018

Study Completion

November 11, 2018

Last Updated

June 20, 2019

Record last verified: 2019-06

Locations

NL(1)