The efficacy and safety of Tirzepatide for type 2 diabetes subjects with chronic kidney disease: prospective observational study

The efficacy and safety of Tirzepatide for type 2 diabetes subjects with chronic kidney disease: prospective observational study - Kushiro T2DCKD-TZP study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051344

Enrollment

Registered

2023-06-16

Start date

2023-06-05

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

Type 2 diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subjects with eGFR less than 60 mL/min/1.73m2 2) Subjects with HbA1c more than 7% 3) Subjects aged 20 years or older at the time of consent 4) Subjects who have been receiving dulaglutide for at least 3 months as pre-treatment 5) Those who have received sufficient explanation before participating in this research, and who have obtained the voluntary consent of the research subject after receiving sufficient understanding, or who do not refuse to participate in the research.

Exclusion criteria

Exclusion criteria: 1) Subjects on erythropoietin stimulating agents or hypoxia-inducible factor-prolyl hydroxylase domain inhibitor 2) Subjects on maintenance hemodialysis or peritoneal dialysis 3) Subjects who are deemed to be unsuitable by the investigator

Design outcomes

Primary

Measure	Time frame
Difference of change in HbA1c after 24 weeks between the tirzepatide and control groups.	—

Secondary

Measure	Time frame
The following changes at 4, 12, and 24 weeks from the beginning of the study 1) Body weight, body mass index, waist circumference and a body shape index 2) Total weight loss rate and excess weight loss rate 3) Blood pressure 4) Fasting plasma glucose 5) Other blood and urine tests (liver, kidney, lipid, bone metabolism, nutrition, endocrine, etc) 6) ABI, CAVI, and PWV in arteriosclerosis testing 7) Dual-energy X-ray absorptiometry 8) Body composition (InBody) 9) Total fat area including of visceral fat mass and subcutaneous fat mass (computed tomography), CT value of liver and spleen, L/S ratio 10) Hepatic steatosis and fibrosis index (calculation from blood tests) 11) the result and diagram from the Eating Behavior Questionnaire 12) the types and severity, etc., of adverse events reported	—

Measure

Time frame

The following changes at 4, 12, and 24 weeks from the beginning of the study 1) Body weight, body mass index, waist circumference and a body shape index 2) Total weight loss rate and excess weight loss rate 3) Blood pressure 4) Fasting plasma glucose 5) Other blood and urine tests (liver, kidney, lipid, bone metabolism, nutrition, endocrine, etc) 6) ABI, CAVI, and PWV in arteriosclerosis testing 7) Dual-energy X-ray absorptiometry 8) Body composition (InBody) 9) Total fat area including of visceral fat mass and subcutaneous fat mass (computed tomography), CT value of liver and spleen, L/S ratio 10) Hepatic steatosis and fibrosis index (calculation from blood tests) 11) the result and diagram from the Eating Behavior Questionnaire 12) the types and severity, etc., of adverse events reported

—

Countries

Japan

Contacts

Public ContactYuki Oe

Kushiro Red Cross Hospital Internal Medicine

o-e.yuki@med.hokudai.ac.jp0154-22-7171

Outcome results