Clinical Pharmacology Study of TS-143 in Nondialysis and Hemodialysis Patients with Chronic Kidney Disease

NCT ID: NCT03581071

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-06
• Study Completion Date: 2017-07-06

Brief Summary

To evaluate the safety, pharmacokinetics, and pharmacodynamics in nondialysis (ND) and hemodialysis (HD) subjects with Chronic Kidney Disease (CKD) who receive a single administration of TS-143.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Step1:1mg in non-dialysis subject

Group Type: EXPERIMENTAL

TS-143

Intervention Type: DRUG

Step2-1:1mg in hemodialysis subjects

Group Type: EXPERIMENTAL

TS-143

Intervention Type: DRUG

Step2-2:6mg in non-dialysis subject

Group Type: EXPERIMENTAL

TS-143

Intervention Type: DRUG

Step3-1:11㎎ in hemodialysis subjects

Group Type: EXPERIMENTAL

TS-143

Intervention Type: DRUG

Step3-2:11㎎ in non-dialysis subject

Group Type: EXPERIMENTAL

TS-143

Intervention Type: DRUG

Interventions

TS-143

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Serum concentration of erythropoietin (EPO): <50 mIU/mL at screening test 1, 2, or 3
• Transferrin saturation ≥ 20% or ferritin ≥ 100 ng/mL at screening test 1
• Subjects meeting any of the following criteria

1. Subjects who has not used erythropoiesis-stimulating agent (ESA) ≥ eight weeks from screening test 1

2. Subjects who has used ESA, other than epoetin beta pegol, ≥ four weeks from screening test 1 and has met all of the following criteria A) to C).

A)The total ESA dosage for each week could be changed within a range of 50%, compared to the total ESA dosage for one week before screening test 1, for four weeks before screening test 1 B)Acceptable to discontinue ESA the day following screening test 1 to Follow-up 2 C)The fluctuating range of Hb concentration between screening tests 1 and 2 is within ±0.5 g/dL per week (the same criteria applied between screening test 2 and 3)

• Subjects who receive an explanation about the study before participating in the study and can understand the contents and are willing and able to provide written consent.

<Criteria for ND subjects>

• CKD subjects who never received dialysis and do not need to receive dialysis during the study period.
• Subjects with an Hb concentration at screening test 1 (ESA present at screening test 2) ≥ 10.0 g/dL to < 13.0 g/dL.
• Subjects with an eGFR at screening test 1 ≥ 15 mL/min/1.73m^2 to < 45 mL/min/1.73m^2.

<Criteria for HD subjects>

• Subjects who received hemodialysis (including diafiltration) three times per week ≥ 12 weeks from acquisition consent.
• Subjects with an Hb concentration at screening test 1 (ESA present at screening test 2) ≥ 10.0 g/dL to < 12.0 g/dL.

Exclusion Criteria

• Subjects with anemia other than that caused by CKD.
• Subjects who have severe infection, systemic hematopathy (e.g. myelodysplastic syndrome, hemoglobinopathy), peptic ulcer or clear hemorrhagic lesion such as gastrointestinal hemorrhage
• Subjects with immune disorder with severe inflammation
• Subjects with uncontrolled secondary hyperparathyroidism
• Subjects who already had or will have a kidney transplantation
• Subjects who have a complication which requires treatment such as proliferative retinopathy, macular edema, or macular degeneration. Or, subjects who had a complication which required treatment such as proliferative retinopathy, macular edema, or macular degeneration within 12 months from screening test 1
• Subjects with congestive heart failure
• Subjects with a medical history of thrombotic disease in the six months from screening test 1
• Subjects with uncontrolled blood pressure; SBP > 170 mmHg or DBP > 100 mmHg at screening test 1 (ESA present, screening tests 1 and 2), (HD subject, evaluated before dialysis)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taisho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shigeru Okuyama

Role: STUDY_DIRECTOR

Taisho Pharmaceutical Co., Ltd.

Locations

Taisho Pharmaceutical Co., Ltd selected site

Tokyo and Other Japanese City, , Japan

Countries

Japan

References

Shinfuku A, Shimazaki T, Fujiwara M, Sato F, Watase H, Numazaki T, Kawakita Y, Mutoh M, Yamasaki H, Takayama N, Kato S, Sugimoto T, Maruyama J. Novel Compound Induces Erythropoietin Secretion through Liver Effects in Chronic Kidney Disease Patients and Healthy Volunteers. Am J Nephrol. 2018;48(3):157-164. doi: 10.1159/000492181. Epub 2018 Sep 3.

Reference Type: BACKGROUND

PMID: 30176654 (View on PubMed)

Other Identifiers

JapicCTI-163383

Identifier Type: OTHER

Identifier Source: secondary_id

TS143-01-02

Identifier Type: -

Identifier Source: org_study_id