NCT02896309

Brief Summary

This study evaluates the effect of oral sodium bicarbonate treatment on the intrarenal renin-angiotensin-system in adult patients with a metabolic acidosis and chronic kidney disease. This treatment is compared to sodium chloride treatment, which serves as control for increased sodium-intake and no treatment, which serves as time-control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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

First Submitted

Initial submission to the registry

August 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2018

Completed
Last Updated

June 20, 2019

Status Verified

June 1, 2019

Enrollment Period

2.3 years

First QC Date

August 18, 2016

Last Update Submit

June 19, 2019

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Urinary renin concentration

    4 weeks

Study Arms (3)

Sodium bicarbonate

EXPERIMENTAL

Oral sodium bicarbonate tablets three times daily 1000mg

Dietary Supplement: Sodium bicarbonate

Sodium chloride

ACTIVE COMPARATOR

Oral sodium chloride capsules two times daily 1000mg

Dietary Supplement: Sodium chloride

No treatment

NO INTERVENTION

No treatment

Interventions

Sodium bicarbonateDIETARY_SUPPLEMENT
Sodium bicarbonate
Sodium chlorideDIETARY_SUPPLEMENT
Sodium chloride

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female adult (≥18 years)
  • chronic kidney disease stage 4, i.e. estimated glomerular filtration rate (MDRD) 15-30 ml/min
  • plasma bicarbonate concentration of 15-24 meq/L

You may not qualify if:

  • bicarbonate level \>24 meq/L or \<15 meq/L, the latter because in that case it seems highly recommended to start sodium bicarbonate suppletion and not to postpone this
  • sodium bicarbonate use in the 1 month preceding the study
  • heart failure
  • liver cirrhosis
  • blood pressure \>140/90 mmHg despite the use of 3 different antihypertensives
  • a kidney transplant in situ
  • a history of nonadherence to medication
  • use of calcineurin inhibitors (these immunosuppressive drugs are known to induce metabolic acidosis and influence electrolytes and acid-base balance)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015CN, Netherlands

Location

Related Publications (4)

  • de Brito-Ashurst I, Varagunam M, Raftery MJ, Yaqoob MM. Bicarbonate supplementation slows progression of CKD and improves nutritional status. J Am Soc Nephrol. 2009 Sep;20(9):2075-84. doi: 10.1681/ASN.2008111205. Epub 2009 Jul 16.

    PMID: 19608703BACKGROUND

  • Ng HY, Chen HC, Tsai YC, Yang YK, Lee CT. Activation of intrarenal renin-angiotensin system during metabolic acidosis. Am J Nephrol. 2011;34(1):55-63. doi: 10.1159/000328742. Epub 2011 Jun 10.

    PMID: 21659740BACKGROUND

  • Nagami GT. Role of angiotensin II in the enhancement of ammonia production and secretion by the proximal tubule in metabolic acidosis. Am J Physiol Renal Physiol. 2008 Apr;294(4):F874-80. doi: 10.1152/ajprenal.00286.2007. Epub 2008 Feb 20.

    PMID: 18287403BACKGROUND

  • Henger A, Tutt P, Riesen WF, Hulter HN, Krapf R. Acid-base and endocrine effects of aldosterone and angiotensin II inhibition in metabolic acidosis in human patients. J Lab Clin Med. 2000 Nov;136(5):379-89. doi: 10.1067/mlc.2000.110371.

    PMID: 11079465BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Sodium BicarbonateSodium Chloride

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsChloridesHydrochloric AcidChlorine Compounds

Study Officials

  • Ewout J Hoorn, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internist nephrologist

Study Record Dates

First Submitted

August 18, 2016

First Posted

September 12, 2016

Study Start

September 1, 2016

Primary Completion

December 27, 2018

Study Completion

December 27, 2018

Last Updated

June 20, 2019

Record last verified: 2019-06

Locations

NL(1)