A randomized controlled trial to verify renoprotective effects by alkali treatment with Uralyt combination tablets in patients with chronic kidney disease and metabolic acidosis

Renoprotective effect and its mechanism by alkali treatment in patients with chronic kidney disease and metabolic acidosis - BALLAD study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041240053

Enrollment

100

Registered

2024-07-01

Start date

2024-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease Chronic kidney disease, metabolic acidosis

Interventions

am A

Uralyt Combination Tablets am B

control

D000284

Administration, Oral

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -chronic kidney disease with metabolic acidosis who meet the following 1)2)3) 1) 18mmol/L<= serum HCO3- <= 22mmol/L 2) 0.15g/gCr <= UPCR 3) 10<= eGFR < 45 -older than 18 years -written consent

Exclusion criteria

Exclusion criteria: -patients who are taking oral alkalinizing agent (bicarbonate, citrate) -K <= 5.5mEq/L -active nephritis or kidney disease -pregnant, or desiring to bear children -inapporopriate for this study as judged by attend ing investigateor

Design outcomes

Primary

Measure	Time frame
eGFR slope during one year of intervention	—

Secondary

Measure	Time frame
1) pH, HCO3- in venous blood gas 2) Serum albumin 3) Cystatin C 4) Albuminuria, proteinuria 5) Urinary L-FABP, NAG 6) Urinary complement activity, blood complement activity 7) Renal events; eGFR decrease by 30% or dialysis initiation or death 8) Urine pH 9) Urinary endothelin 10) Blood pressure, body weight	—

Contacts

Public ContactKato Sawako

Nagoya University Hospital

kato07@med.nagoya-u.ac.jp+81-52-744-2192

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026