Does correction of acidity decrease kidney damage?

• Conditions: Metabolic acidosis in chronic kidney disease; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2013-002037-38-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-30
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- male or female adult (>18 years)
- chronic kidney disease stage 4, i.e. eGFR (MDRD) 15-30 ml/min
- plasma bicarbonate concentration of <24 and >15 meq/L, the latter
because in that case it seems highly recommended to start
sodiumbicarbonate suppletion and not to postpone this
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

- plasma bicarbonate level >24 meq/L or <15 meq/L
- sodiumbicarbonate use in the 1 month preceeding the study
- a kidney transplant in situ
- heart failure
- liver cirrhosis
- resistant hypertension (blood pressure >140/90 mmHg despite the use of 3 or more different antihypertensives
- a history of inadherence to medication
- use of calcineurin inhibitors (these immunosuppressive drugs are
known to induce metabolic acidosis and influence electrolytes and acidbase
balance)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified