Diabetic NephropathiesPhase 1NCT03165240
This International Study Tests BI 690517 in Patients With Diabetic Kidney Disease. The Study Tests How 3 Different Doses of BI 690517 Are Taken up in the Body and How Well They Are Tolerated
A Phase 1 study testing BI 690517 and Eplerenone in people with Diabetic Nephropathies, run by Boehringer Ingelheim at 40 sites in 10 countries.
Trial summary
The primary objective of this current trial is to investigate the safety and tolerability of 3 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy as add-on-therapy to Angiotensin Converting Enzyme inhibitor [ACEi] or Angiotensin-receptor blockers [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 690517 and Eplerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 40 sitesin 10 countries
- Study dates
- 5 Oct 2017to 7 May 2020
- 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 SBP ≥ 110 and ≤ 180 mmHg and 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.
Who cannot join
- Treatment with with SGLT2 inhibitors and/or inhibitors of aldosterone mediated effects like mineralocorticoid receptor antagonists at visit 1 and thereafter.
- Intake of potassium sparing diuretics like amiloride or potassium supplements during the study (this period starts at Visit 1).
- At Visit 1 cortisol peak level 30 minutes (± 5 min) after iv injection of Adrenocorticotropic hormone (ACTH) is an increase by less than 200 nmol/l compared to pre-ACTH injection.
- Dual or triple blockade of the Renin Angiotensin System (RAS) (e.g. ACEi + ARB; ACEi + renin inhibitor; or ARB + renin inhibitor; or ACEi + ARB + renin inhibitor) 12 weeks before Visit 1 and for the duration of study.
- History of non-diabetic renal disease according to investigator's opinion and/or renal transplant recipients.
- Hyperkalaemia (K+ > 5.0 mmol/L) at visit 1 and until start of treatment measured by any local or central lab.
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- Clinical signs of acute or chronic urinary tract infection 14 days before randomization (based on investigator's judgement).
- Acute febrile diseases 14 days before randomisation (based on investigator´s judgement).
- Heart failure, patients with NYHA III / IV.
- Surgery or trauma with significant blood loss or blood donation within 12 weeks prior to first administration of study medication (based on investigator´s judgement) or planned surgeries during the trial e.g. hip replacement (based on investigator's judgement).
- Any other medical condition that in the investigator's opinion poses a safety risk for the patient or may interfere with the study objectives.
- Any laboratory value more than 3 times above upper limit normal (ULN) at screening (visit 1) or any other laboratory value outside the reference range and clinically relevant in the investigator's judgment.
- 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).
- Previous enrolment in this trial.
- Currently enrolled in another investigational device or drug study, or 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 patient or unlikely to complete the trial.
- Women of childbearing potential
- Further exclusion criteria apply
Trial locations and contacts
40 sites in 10 countries.
40 sites in 10 countries
Spain7 sites
Hospital A Coruña
A Coruña, 15006
Hospital Vall d'Hebron
Barcelona, 08035
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Puerta de Hierro
Majadahonda, 28222
Hospital Virgen Macarena
Seville, 41009
Hospital Clínico de Valencia
Valencia, 46010
France5 sites
HOP d'Angers
Angers, 49933
HOP Michallon
La Tronche, 38700
HOP Bichat
Paris, 75018
HOP la Milétrie
Poitiers, 86021
HOP Nord Laënnec
Saint-Herblain, 44800
Germany5 sites
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
InnoDiab Forschung GmbH
Essen, 45136
Inamed GmbH
Gauting, 82131
Medizinische Hochschule Hannover
Hanover, 30625
Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460
Portugal5 sites
Hospital Dr. Nélio Mendonça
Funchal, 9004-514
APDP - Associação Protectora dos Diabéticos de Portugal
Lisbon, 1250-189
CHULN, EPE - Hospital de Santa Maria
Lisbon, 1649-035
Hospital Beatriz Ângelo
Loures, 2674-514
Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António
Porto, 4099-001
Denmark4 sites
Steno Diabetes Center Copenhagen
Gentofte Municipality, DK-2820
Bispebjerg og Frederiksberg Hospital
København NV, 2400
Copenhagen University Hospital, Rigshospitalet
København Ø, 2100
Kolding Sygehus
Kolding, DK-6000
Greece4 sites
Univ. Gen. Hosp. of Ioannina
Ioannina, 45500
Iatriko of Athens Group/ Iatriko of P. Faliro
P. Faliro, 17562
Iatriko Psychikou
Psychikó, 11525
University General Hospital of Thessaloniki AHEPA
Thessaloniki, 54636
Russia4 sites
Res.Inst.-Compl.Iss.Cardi.Dis.
Kemerovo, 650002
City Clinical Hospital named after V.P. Demikhova Department of Health of Moscow
Moscow, 109263
Nonstate Private Healthcare Institution "Scientific Clinical Center of LLC Russian Railways"
Moscow, 125315
Baltic Med,LLC Clinic BaltMed Ozerki
Saint Petersburg, 194356
Sweden4 sites
CTC Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45
Sjukhuset, Härnösand
Härnösand, 871 31
Universitetssjukhuset, Örebro
Örebro, 701 85
CTC Clinical Trial Consultants AB
Uppsala, 75237
About this study
Official title: Randomised, Double-blind, Placebo-controlled (Within Dose Groups) and Active Controlled (Eplerenone Group) Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Oral Doses of BI 690517 Over 28 Days in Female and Male Patients With Diabetic Nephropathy
The primary objective of this current trial is to investigate the safety and tolerability of 3 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy as add-on-therapy to Angiotensin Converting Enzyme inhibitor [ACEi] or Angiotensin-receptor blockers [ARB].
Secondary objective is to evaluate the change from baseline in Urine Albumin-to-Creatinine Ratio [UACR].
- Conditions
- Diabetic Nephropathies
- Being tested
- BI 690517, Eplerenone, 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 690517Drug
Also called Vicadrostat
Film-coated tablet
EplerenoneDrug
Film-coated tablet
PlaceboDrug
Film-coated tablet
| Study group | Role | What they receive |
|---|---|---|
| BI 690517 Dose 1 | Experimental | Not described Receives: Drug: BI 690517 |
| BI 690517 Dose 2 | Experimental | Not described Receives: Drug: BI 690517 |
| BI 690517 Dose 3 | Experimental | Not described Receives: Drug: BI 690517 |
| Eplerenone | Experimental | Not described Receives: Drug: Eplerenone |
| 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-to-Creatinine Ratio (UACR) measured in morning void urine
Measured: Up to 28 days
Change from baseline in log transformed Urine Albumin-to-Creatinine Ratio (UACR) measured in daytime (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 start5 Oct 2017
- Primary completion16 Apr 2020
- Study completion7 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 62 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
- NCT03165240
- Sponsor's protocol ID
- 1378-0008
- Other IDs
- 2017-000563-32, 2017
- Status last verified
- Sep 2024
- First submitted
- 23 May 2017
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bornstein SR, de Zeeuw D, Heerspink HJL, Schulze F, Cronin L, Wenz A, Tuttle KR, Hadjadj S, Rossing P. Aldosterone synthase inhibitor (BI 690517) therapy for people with diabetes and albuminuric chronic kidney disease: A multicentre, randomized, double-blind, placebo-controlled, Phase I trial. Diabetes Obes Metab. 2024 Jun;26(6):2128-2138. doi: 10.1111/dom.15518. Epub 2024 Mar 18.
PubMed 38497241
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled (Within Dose Groups) and Active Controlled (Eplerenone Group) Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Oral Doses of BI 690517 Over 28 Days in Female and Male Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT03165240
- Acronym / sponsor ID
- 1378-0008
- Conditions
- Diabetic Nephropathies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 16 Apr 2020 (actual)
- Study completion
- 7 May 2020 (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 primary objective of this current trial is to investigate the safety and tolerability of 3 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy as add-on-therapy to Angiotensin Converting Enzyme inhibitor [ACEi] or Angiotensin-receptor blockers [ARB].
Secondary objective is to evaluate the change from baseline in Urine Albumin-to-Creatinine Ratio [UACR].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BI 690517 Dose 1 | Experimental | Drug: BI 690517 |
| BI 690517 Dose 2 | Experimental | Drug: BI 690517 |
| BI 690517 Dose 3 | Experimental | Drug: BI 690517 |
| Eplerenone | Experimental | Drug: Eplerenone |
| 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 (10 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 (18 listed)
- Treatment with with SGLT2 inhibitors and/or inhibitors of aldosterone mediated effects like mineralocorticoid receptor antagonists at visit 1 and thereafter.
- Intake of potassium sparing diuretics like amiloride or potassium supplements during the study (this period starts at Visit 1).
- At Visit 1 cortisol peak level 30 minutes (± 5 min) after iv injection of Adrenocorticotropic hormone (ACTH) is an increase by less than 200 nmol/l compared to pre-ACTH injection.
- Dual or triple blockade of the Renin Angiotensin System (RAS) (e.g. ACEi + ARB; ACEi + renin inhibitor; or ARB + renin inhibitor; or ACEi + ARB + renin inhibitor) 12 weeks before Visit 1 and for the duration of study.
- History of non-diabetic renal disease according to investigator's opinion and/or renal transplant recipients.
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 690517Also: VicadrostatFilm-coated tablet | Drug | BI 690517 Dose 1, BI 690517 Dose 2, BI 690517 Dose 3 |
| EplerenoneFilm-coated tablet | Drug | Eplerenone |
| PlaceboFilm-coated tablet | 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-to-Creatinine Ratio (UACR) measured in morning void urine
Time frame: Up to 28 days
Change from baseline in log transformed Urine Albumin-to-Creatinine Ratio (UACR) measured in daytime (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 20 Sep 2024.
- Derived from this study: PubMed 38497241Bornstein SR, de Zeeuw D, Heerspink HJL, Schulze F, Cronin L, Wenz A, Tuttle KR, Hadjadj S, Rossing P. Aldosterone synthase inhibitor (BI 690517) therapy for people with diabetes and albuminuric chronic kidney disease: A multicentre, randomized, double-blind, placebo-controlled, Phase I trial. Diabetes Obes Metab. 2024 Jun;26(6):2128-2138. doi: 10.1111/dom.15518. Epub 2024 Mar 18.
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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.
40 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 690517 and Eplerenone in people with Diabetic Nephropathies, run by Boehringer Ingelheim at 40 sites in 10 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 10 inclusion and 18 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 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Spain, France, Germany, Portugal, Denmark and 5 more countries. 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?
On the ClinicalTrials.gov record for NCT03165240, which also lists 1 linked publication.
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 20 Sep 2024.