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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000563-32 | EudraCT Number |
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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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 690517 Dose 1 | Experimental |
| |
| BI 690517 Dose 2 | Experimental |
| |
| BI 690517 Dose 3 | Experimental |
| |
| Eplerenone | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 690517 | Drug | Film-coated tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with drug related Adverse Events (AEs) | Up to 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in log transformed Urine Albumin-to-Creatinine Ratio (UACR) measured in morning void urine | Up to 28 days | |
| Change from baseline in log transformed Urine Albumin-to-Creatinine Ratio (UACR) measured in daytime (10-hour) urine | Up to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Gentofte Municipality | DK-2820 | Denmark | |||
| Kolding Sygehus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38497241 | Derived | 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. |
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| Eplerenone | Drug | Film-coated tablet |
|
| Placebo | Drug | Film-coated tablet |
|
| Kolding |
| DK-6000 |
| Denmark |
| Bispebjerg og Frederiksberg Hospital | København NV | 2400 | Denmark |
| Copenhagen University Hospital, Rigshospitalet | København Ø | 2100 | Denmark |
| HOP d'Angers | Angers | 49933 | France |
| HOP Michallon | La Tronche | 38700 | France |
| HOP Bichat | Paris | 75018 | France |
| HOP la Milétrie | Poitiers | 86021 | France |
| HOP Nord Laënnec | Saint-Herblain | 44800 | France |
| Universitätsklinikum Carl Gustav Carus Dresden | Dresden | 01307 | Germany |
| InnoDiab Forschung GmbH | Essen | 45136 | Germany |
| Inamed GmbH | Gauting | 82131 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Profil Institut für Stoffwechselforschung GmbH | Neuss | 41460 | Germany |
| Univ. Gen. Hosp. of Ioannina | Ioannina | 45500 | Greece |
| Iatriko of Athens Group/ Iatriko of P. Faliro | P. Faliro | 17562 | Greece |
| Iatriko Psychikou | Psychikó | 11525 | Greece |
| University General Hospital of Thessaloniki AHEPA | Thessaloniki | 54636 | Greece |
| Hospital Dr. Nélio Mendonça | Funchal | 9004-514 | Portugal |
| APDP - Associação Protectora dos Diabéticos de Portugal | Lisbon | 1250-189 | Portugal |
| CHULN, EPE - Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Hospital Beatriz Ângelo | Loures | 2674-514 | Portugal |
| Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António | Porto | 4099-001 | Portugal |
| Res.Inst.-Compl.Iss.Cardi.Dis. | Kemerovo | 650002 | Russia |
| City Clinical Hospital named after V.P. Demikhova Department of Health of Moscow | Moscow | 109263 | Russia |
| Nonstate Private Healthcare Institution "Scientific Clinical Center of LLC Russian Railways" | Moscow | 125315 | Russia |
| Baltic Med,LLC Clinic BaltMed Ozerki | Saint Petersburg | 194356 | Russia |
| D & R s.r.o. | Košice | 040 22 | Slovakia |
| Hospital A Coruña | A Coruña | 15006 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital de Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Puerta de Hierro | Majadahonda | 28222 | Spain |
| Hospital Virgen Macarena | Seville | 41009 | Spain |
| Hospital Clínico de Valencia | Valencia | 46010 | Spain |
| CTC Sahlgrenska Universitetssjukhuset | Gothenburg | 413 45 | Sweden |
| Sjukhuset, Härnösand | Härnösand | 871 31 | Sweden |
| Universitetssjukhuset, Örebro | Örebro | 701 85 | Sweden |
| CTC Clinical Trial Consultants AB | Uppsala | 75237 | Sweden |
| University Hospital of Wales | Cardiff | CF14 4XW | United Kingdom |
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077545 | Eplerenone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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