E11.22 Diabetes mellitus tipo 2 con nefropatia diabetica cronica
Conditions
Interventions
Drug: Placebo 140 patients:
Placebo (0.2 mL) 32 patients,
Placebo (0.4 mL) 32 patients,
Placebo (0.8 mL), 32 patients,
Placebo (2 mL) 44 patients.
Drug: Dapagliflozin
Dapagliflozin 10 mg -
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Adult men or women = 18 years of age at Visit 1. 2 Written informed consent and any locally required authorization (eg, data privacy) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. 3 DKD defined as (a) diagnosis of T2DM and (b) eGFR 25-75 mL/min/1.73 m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation a and (c) UACR defined as 100-3000 mg albumin/g creatinine based on the mean of 3 sequential first morning void midstream urine samples at Visit 2. 4 BP = 150/100 mmHg at Visit 1 and Visit 3. 5 Stable dose of ACEi or ARB for at least 6 weeks prior to Visit 1 with ACEi and ARB dosing according to local guidelines. Subjects who have been deemed unable to tolerate ACEi or ARB therapy due to allergy or complications may be enrolled. Minor dose adjustment within 2 weeks of Visit 1 is acceptable (see Section 4.7.2).
Exclusion criteria
Exclusion criteria: 1 Serum potassium > 5.5 mmol/L 2 Significant hepatic disease 3 Hemoglobin A1c > 10.5 % 4 B-type natriuretic peptide level > 200 pg/mL 5 History of clinically significant heart disease 6 Anticipated dialysis or renal transplantation within 1 year 7 History of underlying condition that predisposes the subject to infections 8 Significant infection (viral, bacterial, or fungal) 9 Amputation due to peripheral artery disease 10 Subjects with a positive diagnostic nucleic acid test for SARS-CoV-2 11 Pregnancy, breastfeeding or intention to become pregnant during the course of the study, 12 Any other medical condition or clinically relevant abnormal findings in physical examination, laboratory results, or electrocardiogram (ECG) during screening that, in the opinion of the investigator, may compromise the safety of the subject in the study, reduce the subject’s ability to participate in the study, or interfere with evaluation of the investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine albumin:creatinine ratio (UACR) NAME OF THE RESULT: Urine albumin:creatinine ratio (UACR), Change from baseline to Day 169 compared to placebo PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From Baseline to Day 169 (24 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| MEDI3506 serum PK concentrations throughout the study NAME OF THE RESULT: PK profile of MEDI3506 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From Visit 1 (Screening) to Day 230 (End of Study) ;To assess hematology, serum chemistry, urinalysis NAME OF THE RESULT: Safety and tolerability by clinical laboratory evaluations PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From Visit 1 (Screening) to Day 230 (End of Study) ;To assess systolic and diastolic blood pressure, heart rate, respiratory rate, temperature, 12-lead electrocardiogram, echocardiogram and physical exam NAME OF THE RESULT: Safety and tolerability by assessment of vital signs PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From Visit 1 (Screening) to Day 230 (End of Study) ;Proportion of subjects with > 30%, 40% or 50% reduction NAME OF THE RESULT: Urine albumin:creatinine ratio (UACR) reduction PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: At Day 169, baseline to Day 85 (12 weeks) or Day 85 to Day 169 ;Anti-drug antibodies (ADAs) incidence throughout the study NAME OF THE RESULT: Immunogenicity of MEDI3506 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From Visit 1 (Screening) to Day 230 (End of Study) ;To assess the number Treatment Emergent Adverse events (TEAEs), Serious Adverse Events (SAEs), Treatme | — |
Countries
Canada, Japan, United States
Contacts
Public ContactFlor de Liz Jacome
LABCORP PERU SERVICES S.A.
Outcome results
None listed