Diabetic NephropathiesPhase 1NCT03165227
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)
A Phase 1 study testing BI 685509 in people with Diabetic Nephropathies, run by Boehringer Ingelheim at 35 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- BI 685509
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 35 sitesin 5 countries
- Study dates
- 17 Oct 2017to 10 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Male or postmenopausal (last menstruation ≥ 2 years ago) patients, or female patients who are sterilized by either hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy. Male patients with partners of child-bearing potential must be willing to use condoms from the time of the first intake of study drug until follow-up.
- eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥ 20 and < 75 ml/min/1.73 m2 at Visit 1 measured by the central laboratory and no planned start of renal replacement therapy during the trial
- UACR ≥ 200 and <3500 mg/g in spot urine (midstream urine sample) at Visit 1 measured by the central laboratory
- Treatment with either ACEi or ARB, stable dose since ≥ 4 weeks before Visit 1 with no planned change of the therapy
- Patients with type 1 or type 2 diabetes mellitus, diagnosed before informed consent and treated with insulin, glucagon-like peptide (GLP) 1 agonists and/or oral antidiabetic medication. Treatment should have been unchanged (investigator's judgment) within 4 weeks before Visit 1 and until randomisation
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- Glycated Haemoglobin (HbA1c) < 10.0% at Visit 1 measured by the central laboratory
- Seated Systolic Blood Pressure (SBP) ≥ 110 and ≤ 180 mmHg and Diastolic Blood Pressure (DBP) ≥ 70 and ≤ 110 mmHg at Visit 1
- Age at screening ≥ 18 years for male and permanently sterilized female patients and ≥ 45 years for postmenopausal female patients
- Body Mass Index (BMI) ≥ 18.5 and < 45 kg/m2
- Successful ABPM reading before randomisation, upper arm circumference within the circumference level of the cuff size of either ABPM and/or BP measurement device used in the study
Who cannot join
- Treatment with SGLT2 inhibitors and/or phosphodiesterase inhibitors, nitrates or riociguat, from screening (Visit 1) or within 5 half-lives before randomisation whatever is earlier.
- Any laboratory value more than 3 times above upper limit of normal (ULN) at screening (Visit 1) or any other laboratory value outside the reference range and clinically relevant (for safe participation) in the investigator judgment
- Confirmed non-diabetic renal disease in the opinion of investigator
- Any other medical condition that in the investigator's opinion poses a safety risk for the patient or may interfere with the study objectives including
- symptomatic heart failure (NYHA III/IV),
- known history of tachycardia and/or atrial fibrillation
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- clinically relevant arrhythmias
- coronary heart disease not compensated by medical treatment (supine pulse rate >70 beats per minute, existing angina pectoris)
- <6 months after myocardial infarction.
- Medical history of cancer or treatment for cancer in the last two years prior to Visit 1 (except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix, and prostatic cancer of low grade [T1 or T2] is exempted)
- Surgery or trauma with significant blood loss (investigator's judgement) within the last 3 months prior to informed consent or significant blood donation (investigator's judgement) within four weeks prior to first administration of study medication or planned during the trial
- Previous randomization in this trial
- Currently enrolled in another investigational device or drug study, i.e., less than 30 days since ending another investigational device or drug study(s), or receiving other investigational treatment(s)
- Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable study subject or unlikely to complete the trial
- Women of childbearing potential
- Further exclusion criteria apply
Trial locations and contacts
35 sites in 5 countries.
35 sites in 5 countries
United States22 sites
Research by Design, LLC
Chicago, Illinois, 60643
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
Research Institute of Dallas
Dallas, Texas, 75231
Creekside Endocrine Associates, PC
Denver, Colorado, 80246
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312
Indago Research and Health Center
Hialeah, Florida, 33012
Houston Clinical Research Associates
Houston, Texas, 77090
Nephrology Consultants, LLC
Huntsville, Alabama, 35805
Knoxville Kidney Center PLLC
Knoxville, Tennessee, 37923
California Institute of Renal Research
La Mesa, California, 91942
South Florida Research Institute
Lauderdale Lakes, Florida, 33313
Scott Research, Inc.
Laurelton, New York, 11413
Office of Dr. Richard S. Cherlin
Los Gatos, California, 95032
Boise Kidney and Hypertension Institute
Meridian, Idaho, 83642
San Marcus Research Clinic, Inc.
Miami, Florida, 33014
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, 33166
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112
York Clinical Research, LLC
Norfolk, Virginia, 23510
Science Advancing Medicine Clinical Research Center
San Antonio, Texas, 78229
Northwest Louisiana Nephrology L.L.C.
Shreveport, Louisiana, 71101
Genesis Clinical Research
Tampa, Florida, 33614
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
Belgium5 sites
Bonheiden - HOSP Imelda
Bonheiden, 2820
Brussels - UNIV UZ Brussel
Brussels, 1090
Edegem - UNIV UZ Antwerpen
Edegem, 2650
UNIV UZ Gent
Ghent, 9000
Centre Hospitalier Universitaire de Liège
Liège, 4000
Czechia5 sites
University Hospital Brno
Brno, 625 00
St. Anna Hospital, 2nd Internal Department
Brno, 656 91
Quinta Analytica
Prague, 10200
Institute for Clinical and Experimental Medicine
Prague, 140 21
General University Hospital in Prague
Prague, 169 00
Germany2 sites
SocraTec R&D GmbH
Erfurt, 99084
CTC North GmbH & Co. KG, Hamburg
Hamburg, 20251
About this study
Official title: Randomised, Double-blind, Placebo-controlled Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Multiple Rising Oral Doses of BI 685509 Over 28 Days in Male and Female Patients With Diabetic Nephropathy
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
- Being tested
- BI 685509, Placebo
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 685509Drug
Taken orally
PlaceboDrug
Taken orally
| Study group | Role | What they receive |
|---|---|---|
| BI 685509 Dose 1 | Experimental | Not described Receives: Drug: BI 685509 |
| BI 685509 Dose 2 | Experimental | Not described Receives: Drug: BI 685509 |
| BI 685509 Dose 3 | Experimental | Not described Receives: Drug: BI 685509 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with drug related Adverse Events (AEs)
Measured: Up to 35 days
Secondary outcomes (2)
Change from baseline in log transformed Urine albumin creatinine ratio (UACR) measured in morning void urine
Measured: Up to 28 days
Change from baseline in log transformed Urine albumin creatinine ratio (UACR) measured in 10-hour urine
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start17 Oct 2017
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165227
- Sponsor's protocol ID
- 1366-0004
- Other IDs
- 2014-004541-27, 2014
- Status last verified
- Jan 2020
- First submitted
- 23 May 2017
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Multiple Rising Oral Doses of BI 685509 Over 28 Days in Male and Female Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT03165227
- Acronym / sponsor ID
- 1366-0004
- Conditions
- Diabetic Nephropathies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BI 685509 Dose 1 | Experimental | Drug: BI 685509 |
| BI 685509 Dose 2 | Experimental | Drug: BI 685509 |
| BI 685509 Dose 3 | Experimental | Drug: BI 685509 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Male or postmenopausal (last menstruation ≥ 2 years ago) patients, or female patients who are sterilized by either hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy. Male patients with partners of child-bearing potential must be willing to use condoms from the time of the first intake of study drug until follow-up.
- eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥ 20 and < 75 ml/min/1.73 m2 at Visit 1 measured by the central laboratory and no planned start of renal replacement therapy during the trial
- UACR ≥ 200 and <3500 mg/g in spot urine (midstream urine sample) at Visit 1 measured by the central laboratory
- Treatment with either ACEi or ARB, stable dose since ≥ 4 weeks before Visit 1 with no planned change of the therapy
Key exclusion criteria (16 listed)
- Treatment with SGLT2 inhibitors and/or phosphodiesterase inhibitors, nitrates or riociguat, from screening (Visit 1) or within 5 half-lives before randomisation whatever is earlier.
- Any laboratory value more than 3 times above upper limit of normal (ULN) at screening (Visit 1) or any other laboratory value outside the reference range and clinically relevant (for safe participation) in the investigator judgment
- Confirmed non-diabetic renal disease in the opinion of investigator
- Any other medical condition that in the investigator's opinion poses a safety risk for the patient or may interfere with the study objectives including
- Medical history of cancer or treatment for cancer in the last two years prior to Visit 1 (except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix, and prostatic cancer of low grade [T1 or T2] is exempted)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 685509Taken orally | Drug | BI 685509 Dose 1, BI 685509 Dose 2, BI 685509 Dose 3 |
| PlaceboTaken orally | Drug | Placebo |
Primary outcome
Percentage of patients with drug related Adverse Events (AEs)
Time frame: Up to 35 days
2 secondary outcomes
Change from baseline in log transformed Urine albumin creatinine ratio (UACR) measured in morning void urine
Time frame: Up to 28 days
Change from baseline in log transformed Urine albumin creatinine ratio (UACR) measured in 10-hour urine
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 685509 in people with Diabetic Nephropathies, run by Boehringer Ingelheim at 35 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Belgium, Czechia, Germany, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with drug related Adverse Events (AEs) (time frame: Up to 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.