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This Study Tests a New Medicine Called BI 685509 in Patients That Have Kidney Problems Because of Diabetes. The Study Tests How BI 685509 is Taken up in the Body and How Well it is Tolerated (Multiple Rising Doses)

NCT03165227 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-01-13

No results posted yet for this study

Summary

The main objective of this trial is the safety and tolerability of 3 multiple rising oral doses of BI 685509 over 28 days in male and female patients with Diabetic Nephropathy (DN) as adjunctive to Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB). Another objective is the change in Urine Albumin Creatinine Ratio (UACR), an important diagnostic marker of nephropathy.

Conditions

  • Diabetic Nephropathies

Interventions

DRUG

BI 685509

Taken orally

DRUG

Placebo

Taken orally

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-17
Primary Completion
2019-12-10
Completion
2019-12-10
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03165227 on ClinicalTrials.gov