diabetic nephropathy MedDRA version: 21.1 Level: PT Classification code 10061835 Term: Diabetic nephropathy System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Code: APX-115
Pharmaceutical Form: Capsule
INN or Proposed INN: INN Requested
Current Sponsor code: APX-115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Aptabio Therapeutics, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Male/female subject, aged 18 to 80 years inclusive at the time of informed consent; 2- Clinical Diagnosis of type 2 diabetes; 3- 18.5 kg/m² =65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: 1- Female subject who is pregnant or breastfeeding. Female subject should not be enrolled if she plans to become pregnant during the time of study participation; 2- History of type 1 diabetes mellitus or gestational diabetes; 3- Subject’s renal impairment and/or albuminuria is considered to be of origin other than Diabetic Kidney Disease; 4- History of renal transplant and/or plan to undergo a renal transplant during the course of the study; 5- History of acute kidney injury (AKI) or renal dialysis within 3 months prior to screening and/or plan to unergo a renal dialysis during the course of the study; 6- Subject with uncontrolled blood pressure o Despite the use of three or more antihypertensive drugs, subject with uncontrolled hypertension with blood pressure greater than SBP 140 mmHg / DBP 90 mmHg o Subject with clinically significant hypotension by the discretion of the investigator; 7- Subject taking two or more RAS blockers (ACE inhibitor, ARB, aldosterone antagonist); 8- Subject taking immunosuppressant including steroids, cyclosporine, or tacrolimus, or other immunosuppressant drugs; 9- Clinically significant abnormal laboratory findings at screening including : o serum potassium > 5.5 mEq/L; o ALT > three times upper limit normal; o AST > three times upper limit normal; o total bilirubin > three times upper limit normal; o serum creatinine > 2 mg/dL; 10- History of drug or alcohol abuse within 1 year prior to screening; 11- History of any cardiovascular event (e.g. myocardial infarction, unstable angina within 6 months prior to screening) OR cardiovascular procedure planned during the clinical trial(e.g., revascularization procedure such as stent or bypass graft surgery); 12- Current or history of NYHA class IV heart failure; 13- Clinically significant ECG abnormalities on a 12-lead ECG at the screening visit or before randomization: o QTcf = 430 ms for male and = 450 ms for female o new clinically important arrhythmia or conduction disturbance; 14- Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis) 15- Subject with active urinary tract infection or has not fully recovered before randomization; 16- History of malignancy within 5 years prior to screening (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ, or a malignancy that in the opinion of the investigator, with concurrence with the sponsor, is considered cured with minimal risk of recurrence); 17- Administration of any investigational product within 30 days or within 5 half-lives of the investigational product; 18- Diagnostic or interventional procedure requiring a contrast agent within 4 weeks before the screening visit or planned during the course of the study; 19- Major surgery within 28 days or not fully recovered surgery prior to randomization or major surgery planned during the next 6 months; 20- Positive HBs antigen or anti HCV antibody, or positive results for HIV 1 or 2 tests; positive for FANA (at a titre of greater than 1:80), ANCA, RF; 21- Other medical history which in the opinion of the investigator would make the subject unsuitable for participation in the study; 22- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental status.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the anti-albuminuric effects of APX-115 in subjects with type 2 diabetes and nephropathy.;Secondary Objective: • To evaluate the safety and tolerability of APX-115 in subjects with type 2 diabetes and nephropathy. • To evaluate the mean change in eGFR between baseline and Week 12. • To assess the pharmacodynamics of APX-115 by measurement of oxidative stress markers Exploratory Objective: • To evaluate the pharmacokinetics of APX-115 in subjects with type 2 diabetes and nephropathy • To evaluate the thyroid function between baseline and week 12.;Primary end point(s): Mean change in UACR at Week 12 from baseline in APX-115 treatment group compared to placebo group.;Timepoint(s) of evaluation of this end point: week 12 and baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Assessment of safety and tolerability : o Adverse Events / Serious Adverse Events; o Physical examinations; o Vitals signs; o Clinical laboratory measurements (chemistry, hematology, coagulation and urinalysis); o ECG. • Change in eGFR using CKD-EPI formula at Week 12 from baseline in APX-115 treatment group compared to placebo group. • Assessment of the pharmacodynamics of APX-115 between baseline and Week 12: o Change in plasma biomarkers: MCP-1 and 8-isoprostane o Change in urinary biomarkers: 8-isoprostane, kidney injury molecule 1 (KIM-1), Cubilin, and 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-OHdG) Exploratory endpoint • Plasma concentrations of APX-115 and other metabolites as appropriate • Assessment of the thyroid function: free T4 and TSH ;Timepoint(s) of evaluation of this end point: each study visit | — |
Countries
Bulgaria, Czech Republic, Hungary, Serbia
Contacts
Public ContactPauline Leveille, project manager
EUROFINS OPTIMED
Outcome results
None listed