Diabetic kidney disease in patients with type 2 diabetes MedDRA version: 18.0 Level: LLT Classification code 10045250 Term: Type II diabetes mellitus with renal manifestations System Organ Class: 100000004857
Conditions
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Known type 2 diabetes with a diagnosis made at age =30 years or later and =8 years prior to selection - Estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation within the 20-60 mL/min/1.73 m2 range - Urinary albumin-to-creatinine ratio (UACR) >300 mg/g. - Treatment by angiotensin converting enzyme (ACE) inhibitor or by angiotensin-II receptor blocker (ARB) unless medically justified and documented; at a stable dose for at least 6 weeks prior to selection visit 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 185 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 185
Exclusion criteria
Exclusion criteria: - Fever or infection requiring treatment with systemic anti-infectives within 3 weeks prior to selection - Major general surgery within 3 months prior to selection, or anticipated during the study period - Treatment with biological agents within within 6 weeks (for anti TNF a ie: pentoxifylline, anti-IL1) or within 3 months prior to inclusion visit for (but not restrictive to) interferon, infliximab, daclizumab, etanercept, anakinra, canakinumab or adalimumab, either marketed or investigational medicinal products),(other than antivitreal anti VEGF which are allowed) - Any immunosuppressive therapy within 3 months prior to inclusion - Any systemic corticosteroids (>20 mg/day of prednisolone or equivalent) within 1 month prior to inclusion - Any live (attenuated) vaccine within 3 months prior to inclusion; recombinant or killed virus vaccines are permitted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to detect the existence of an overall dose-response relationship with gevokizumab SC, on the measured glomerular filtration rate in patients with type 2 diabetes and diabetic kidney disease;Secondary Objective: The secondary objectives are to assess the effect of gevokizumab on the other efficacy endpoints and to evaluate its safety.;Primary end point(s): Measured Glomerular Filtration Rate (mGFR);Timepoint(s) of evaluation of this end point: From inclusion to Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Estimated GFR (eGFR) calculated with serum creatinine and/or serum cystatin C-based equations - Albuminuria, estimated by measuring the urinary albumin to creatinine ratio (UACR) ;Timepoint(s) of evaluation of this end point: From inclusion to the end of the study | — |
Countries
Argentina, Australia, Belgium, Canada, Czech Republic, Denmark, Germany, Hong Kong, Korea, Republic of, Poland, Portugal, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan
Contacts
Public ContactClinical Studies Department
Institut de Recherches Internationales Servier
Outcome results
None listed