E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
type II diabetic mellitus (T2DM) patients with a clinical diagnosis of diabetic kidney disease (CKD) |
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E.1.1.1 | Medical condition in easily understood language |
type II diabetic patients with a diabetic kidney disease |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Investigate the change in UACR from baseline values obtained at Visit 1 to 6 months after treatment with BAY 1142524, in comparison to placebo, on top of standard of care therapy. |
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E.2.2 | Secondary objectives of the trial |
Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Patients with T2DM and a clinical diagnosis of DKD (as judged by the investigator) who have finished their up-titration with an ARB or ACEI to their maximum tolerated dose at least 3 months prior to the screening visit, whereby the maximum tolerated dose has to be at least as high as the minimal recommended dose of an ARB or ACEI according to local and/or international guidelines. Patients have to be treated with an ARB or ACEI, but not with both simultaneously, without any adjustments to this therapy for at least 4 weeks prior to the screening visit. 2. UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit 3. eGFR ≥30 mL/min/1.73 m2 and <90 mL/min/1.73 m2 ((Chronic Kidney Disease Epidemiology Collaboration [CKD EPI]) at the screening visit and the baseline visit) Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit |
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E.4 | Principal exclusion criteria |
1. Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator 2. Known bilateral clinical relevant renal artery stenosis (>75%) 3. New York Heart Association (NYHA) Class IV 4. Acute kidney injury or dialysis within the last 3 months before the screening visit 5. Renal replacement therapy during study conduct 6. Renal allograft in place or a scheduled kidney transplant during study conduct 7. Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit 8. Clinically relevant hepatic dysfunction 9. Uncontrolled hypertension as evidenced by systolic blood pressure >160 mmHg, or diastolic blood pressure >100 mmHg (mean of triplicate values at the screening or baseline visit after at least 10 minutes rest in sitting position |
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E.5 End points |
E.5.1 | Primary end point(s) |
Ratio of UACR at Visit 6 (167 ±14 days after Visit 1) to UACR at Visit 1 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
UACR will be assessed before the start of treatment with study drug (Visit 1) and after 6 months of treatment with study drug (Visit 6) for the primary variable. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Biomarker and Tolerability |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Bulgaria |
Denmark |
Finland |
Israel |
Italy |
Spain |
Sweden |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |