Unique ID issued by UMIN | UMIN000051442 |
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Receipt number | R000058674 |
Scientific Title | The renal benefits of Tirzepatide for type 2 diabetes subjects with chronic kidney disease: prospective observational study |
Date of disclosure of the study information | 2023/06/25 |
Last modified on | 2023/06/24 14:45:30 |
The renal benefits of Tirzepatide for type 2 diabetes subjects with chronic kidney disease: prospective observational study
Kushiro CKD-TZP long-term study
The renal benefits of Tirzepatide for type 2 diabetes subjects with chronic kidney disease: prospective observational study
Kushiro T2DCKD-TZP long-term study
Japan |
Type 2 diabetes
Medicine in general | Endocrinology and Metabolism | Nephrology |
Others
NO
To evaluate the effects on renal function of Trizepatide switching from conventional glucagon-like peptide-1 receptor agonist in Japanese type 2 diabetes subjects with chronic renal disease.
Safety,Efficacy
Difference of change in eGFR after 24 weeks between the tirzepatide and control groups.
The following changes at 4, 12, 24, and 52 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, HbA1c
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) Visceral fat mass and subcutaneous fat mass (computed tomography)
10) Hepatic steatosis and fibrosis index (calculation from blood tests)
11) the result and diagram from the Eating Behavior Questionnaire
12) Renal composite endpoint (doubling of serum creatinine, sustained eGFR decline of 50% or longer, end-stage renal failure (dialysis, renal transplantation, eGFR<15 mL/min/1.73 m2), death from renal disease, etc.)
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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.
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
50
1st name | Yuki |
Middle name | |
Last name | Oe |
Kushiro Red Cross Hospital
Internal Medicine
060-8638
21-14, Shineichyo, Kushiro, Hokkaido, Japan.
0154-22-7171
o-e.yuki@med.hokudai.ac.jp
1st name | Yuki |
Middle name | |
Last name | Oe |
Kushiro Red Cross Hospital
Internal Medicine
060-8638
21-14, Shineichyo, Kushiro, Hokkaido, Japan.
0154-22-7171
o-e.yuki@med.hokudai.ac.jp
Kushiro Red Cross Hospital
Yuki Oe
Kushiro Red Cross Hospital
Self funding
Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Ethics Committee of Kushiro Red Cross Hospital
21-14, Shineichyo, Kushiro, Hokkaido, Japan.
0154-22-7171
r.cross@kushiro.jrc.or.jp
NO
2023 | Year | 06 | Month | 25 | Day |
Unpublished
Enrolling by invitation
2023 | Year | 05 | Month | 25 | Day |
2023 | Year | 06 | Month | 05 | Day |
2023 | Year | 06 | Month | 05 | Day |
2027 | Year | 06 | Month | 30 | Day |
To evaluate the effects on renal function of Trizepatide switching from conventional glucagon-like peptide-1 receptor agonist in Japanese type 2 diabetes subjects with chronic renal disease.
2023 | Year | 06 | Month | 24 | Day |
2023 | Year | 06 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058674
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