NCT05086549

An Observation Study to Evaluate the Renoprotective Effect of Fimasartan in Patients With DKD and Proteinuria

A Multicenter, Prospective, Observational Study to Evaluate the Renoprotective Effect of Fimasartan in Patients With Diabetic Kidney Disease and Proteinuria

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 360 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study aims to observe changes in various indicators of renal function, such as proteinuria at different time points: short-term (Week 8), 6 months (Week 26), and a year (Week 52), in patients with DKD and hypertension, who are given antihypertensives containing fimasartan, in an actual clinical environment where a variety of patient characteristics are reflected.

Detailed description

This prospective observational study is conducted in about 5 medical institutions located in Korea, which are equal to or larger than a hospital, and patients with type 2 diabetic kidney disease (proteinuria with an ACR of 10 mg/g or higher), who are being administered or plan to be administered with antihypertensives containing fimasartan for essential hypertension, are enrolled as the subjects. Each of the subjects shall undergo follow-up for about a year (52 weeks). After explaining the purpose, method, scope of information to be collected, and procedure of this study to potential subjects, the investigator shall obtain the written consent for voluntary participation and set the day when the antihypertensive containing fimasartan is administered as the baseline. If the fimasartan-based antihypertensive treatment is already ongoing, only the patients within 6 weeks from the baseline shall be considered as the subjects. In this case, data from between the baseline and the time of the written consent shall be collected retrospectively. This study is an observational study, and the drugs which are administered during the study period and the medical procedures shall be in accordance with the clinical judgment of the investigator. It is a rule that no unnecessary intervention shall be imposed on the subjects by this study protocol. The scope of data to be collected during this study period is as follows. * Demographic information * Disease information (diabetes, hypertension, renal disease, other past medical history and intercurrent diseases) * Physical measurements (height and weight) * Clinic blood pressure measurements * Laboratory test results * Antihypertensives, hypoglycemic agents, and other concomitant drugs * Fimasartan-related adverse drug reactions and serious adverse drug reactions * Death information (if applicable)

Conditions

• Diabetic Kidney Disease
• Proteinuria
• Hypertension,Essential

Timeline

• Start date: 2021-09-29
• Primary completion: 2023-06-05
• Completion: 2023-06-05
• First posted: 2021-10-21
• Last updated: 2023-07-12

Locations

1 site across 1 country: South Korea