Femme et Homme | 18 ans et plus
- | Pays :
- France
- | Organes :
- Rein
- Prostate
- | Spécialités :
- Pharmacologie - Recherche de Transfert
Extrait
A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis.
Extrait Scientifique
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA). There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.;
Objectif principal
The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis;
Critère d'inclusion
- Estimated glomerular filtration rate (eGFR) 20 - 40 mL/min/1.73m^2.
- Serum bicarbonate 12 - 20 mEq/L.
- On maximum tolerated dose of ACE inhibitor and/or ARB.
Critère de non inclusion
- Acute metabolic acidosis.
- Anticipated dialysis or kidney transplant within 6 months.
- Recent acute kidney injury.