Parallel-group Comparative Study of TCF-12 in Patients with Chronic Kidney Disease

A Multicenter, Randomized, Placebo-controlled Double-blind, Oral Adsorbent-controlled Open-label, Parallel-group Comparative Exploratory Study to Evaluate the Efficacy and Safety of Oral Administration of TCF-12 in Patients with Chronic Kidney Disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223963

Enrollment

150

Registered

2018-07-02

Start date

2018-07-16

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(GFR category:G3b or G4)

Interventions

investigational material(s) Generic name etc : TCF-12 INN of investigational material : - Therapeutic category code : 392 Antidotes Dosage and Administration for Investigational material : Oral admini

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Main Inclusion Criteria -Chronic Kidney Disease -eGFR(mL/min/1.73 m2) >= 15,45 > eGFR(mL/min/1.73 m2) -Serum indoxyl sulfate level >= 0.5 mg/dL

Exclusion criteria

Exclusion criteria: Main Exclusion Criteria -Patients who have gastrointestinal obstruction -Patients who have kidney diseases such as rapidly progressive glomerular nephritis,hydronephrosis, obstructive urinary tract disease, drug-induced nephropathy, severe nephrotic syndrome, polycystic kidney disease, or transplanted kidney -Patients who have liver dysfunction or cirrhosis of the liver -Patients who have poor blood pressure control -Patients who have poor glycaemic control -Patients who have heart failure(New York Heart Association classes lll to lV) -Patients who had myocardial infarction, unstable angina pectoris, cerebral infarction, or cerebral hemorrhage for 6 months prior to registration -Patients who have the history of malignant tumor in the past 5 years -BMI = 30

Design outcomes

Primary

Measure	Time frame
efficacy The change of serum indoxyl sulfate level from baseline	—

Secondary

Measure	Time frame
safety efficacy Efficacy -Serum indoxyl sulfate and p-cresyl sulfate -Urinary indoxyl sulfate and p-cresyl sulfate -Serum creatinine -eGFR -Urinary protein and albumin -BUN -Cystatin C -Creatinine clearance Safety -Adverse events,Vital signs,Body weights,Standard 12-lead ECG,Clinical laboratory tests	—

Countries

Japan

Outcome results

None listed

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