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

JRCT ID: jRCTs041240053

Registered date:01/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic kidney disease
• Date of first enrollment: 01/07/2024
• Target sample size: 100
• Study type: Interventional

Intervention(s)

am A ; Uralyt Combination Tablets
am B ; control

Outcome(s)

• Primary Outcome: eGFR slope during one year of intervention

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Maruyama Shoichi
• Source(s) of Monetary Support: Nippon Chemiphar Co., Ltd.