Post Marketing Surveillance of JARDIANCE in Chronic Kidney Disease

NCT06527846 | Active Not Recruiting

• 1 other identifier: 1245-0340
• Study Type: observational
• Target: 1,024
• Locations: 1 country
• Sites: 1

Brief Summary

Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic kidney disease under real-world use.

Conditions

Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Drug Reactions (ADRs)

  Up to 52 weeks

Secondary Outcomes (5)

• Kidney disease progression

  Up to 52 weeks

• Incidence of cardiovascular death

  Up to 52 weeks

• Incidence of all cause death

  Up to 52 weeks

• Incidence of hospitalization for heart failure

  Up to 52 weeks

• Change from baseline in eGFR to the last observation on treatment

  at baseline, at last observation on treatment (Up to 52 weeks)

Study Arms (1)

Patients with chronic kidney disease (CKD)

Drug: JARDIANCE®

Interventions

JARDIANCE® DRUG

JARDIANCE®

Also known as: Empagliflozin

Patients with chronic kidney disease (CKD)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic kidney disease (CKD) who are prescribed JARDIANCE® Tablets for CKD according to the current Japanese package insert and never been treated with JARDIANCE® Tablets before enrolment.

You may qualify if:

• Patients with CKD who are prescribed JARDIANCE® Tablets for CKD according to the current Japanese package insert and who provided written informed consent prior to enrolment in this study.
• Patients who have never been treated with JARDIANCE® Tablets (including treatment for Type 2 diabetes mellitus (T2DM) and/or chronic heart failure (CHF)) before enrolment.

You may not qualify if:

• None

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, 1416017, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 30, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

JP (1)