type II diabetic patients with diabetic nephropathy and albuminuria MedDRA version: 19.0 Level: HLT Classification code 10012658 Term: Diabetic complications renal System Organ Class: 100000004860
Conditions
Interventions
Product Name: SER150 ER
Pharmaceutical Form: Capsule, hard
Current Sponsor code: SER150TBS
Other descriptive name: SER150 ER capsules 15 mg
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
Serodus ASA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females 2. Aged 18 to 85 years, inclusively 3. Female patient is either post-menopausal (presents at least a 12 month period of amenorrhea in women aged = 55 years and two years in those aged 300 mg/g) 9. ALAT, or ASAT values not exceeding 1.5x ULN 10. ALP, PT (or its international normalized ratio (INR)) and bilirubin within normal values 11. eGFR equal or above 30 ml/min (CKD-Epi-formula) 12. Glycated haemoglobin (HbA1c) = 7.5%. A HbA1c value up to 8.5 % is acceptable in well controlled patients (according to the investigator’s opinion), particularly in elderly patients 13. Normal blood pressure or well controlled hypertension (maximum 140 mm Hg systolic and 90 mm Hg diastolic) Ethical/Other: 14. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 47 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 47
Exclusion criteria
Exclusion criteria: 1. Recent history or ongoing liver disease, including viral infections (Hepatitis A/B/C/D/E, Coxsackie, or other viral infections of the liver) 2. ALAT or, ASAT values exceeding 1.5x ULN 3. ALP, PT (or its international normalized ratio (INR)) or bilirubin values exceeding the ULN 4. Stroke within the last 3 months 5. Systemic infections during the last month 6. Severe renal failure (eGFR under 30 ml/min, CKD-Epi-formula) 7. Chronic treatment with non-steroidal anti-inflammatory drugs (NSAID) including regular dose aspirin. Low dose aspirin treatment up to 100 mg/d is allowed. 8. Any bleeding disorder or acute blood coagulation defect 9. A history of gastric ulcers or any other organic lesion susceptible to bleeding 10. Subjects who have undergone any kind of surgery in the last 2 weeks before IMP/placebo administration 11. Others: allergy to the active substance or any of the excipients of the IMP 12. Pregnant or lactating women 13. Only for participation in the second cohort: Patients having participated in the first cohort 14. Present participation in another clinical study or having participated in a clinical study requiring the administration of an investigational medicine, 6 months prior to enrolment (i.e. no interaction with the previous investigational medicine should be possible) 15. History of serious cardiac disease, defined as myocardial infarction within three months of inclusion, congestive heart failure classified by the New York Heart Association as Class III or IV, poorly controlled or unstable angina, electrocardiographic evidence of acute ischemia, or clinically significant cardiac arrhythmias (i.e. the patient should have no symptoms and need no specific treatment, or have an appropriate treatment with successful control) Ethical/Other: 16. Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities 17. Subjects dependent on the sponsor, investigators, personnel of the trial site or any other individual whose willingness to volunteer may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine sequentially the safety of two different doses of SER150TBS administration (15 mg and 30 mg) repeated BID orally during 28 consecutive days, in well controlled type II adult diabetic patients with diabetic nephropathy and albuminuria, in stable antidiabetic treatment, by determining predefined safety hepatic and renal function parameters. To assess, in the mentioned setting, the efficacy of SER150TBS administration, determining the change in the amount of albuminuria and the amount of urinary thromboxane after 2 and 4 weeks of treatment as compared to that of placebo.;Secondary Objective: To determine in the mentioned setting the tolerability of SER150TBS administration by assessing the observed adverse reactions.;Primary end point(s): Effects of SER150TBS on kidney function, assessed by the change in the amount of albuminuria and the amount of urinary thromboxane after 2 and 4 weeks of treatment as compared to that of placebo;Timepoint(s) of evaluation of this end point: screening visit V1 (day -14 to day -7), the mid-study visit V3 (day 14 ± 1), and the end of treatment visit V4 (day 28 ± 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - serum creatinine and the corresponding eGFR (the central lab uses the CKD-Epi-formula) - urine protein to creatinine ratio. Additional parameter during the second cohort of patients For patients participating in cohort 2, the potential effect of SER150 on inflammation will be explored by determining (C-reactive protein (CRP)) in blood.;Timepoint(s) of evaluation of this end point: screening visit V1 (day -14 to day -7), the mid-study visit V3 (day 14 ± 1), and the end of treatment visit V4 (day 28 ± 1). | — |
Countries
Germany
Contacts
Public ContactFrankfurt Office
Ecron Acunova GmbH
Outcome results
None listed