Total: 14 projects
Actively involved in Renal Research Inc.
2001 to Present
“Roche” Multicenter Trial on erthropoeitic agents in anemia
Novartis CERL080AUS67 (2008-2009). A multi-centerm randomized, double blid, double dummy controlled study to assess the tolerability of an increased dose of myfortic® after conversion from CellCept® dose reductions due to gastrointestinal symptoms.
CERA BH18387 (2005-2008). An open-label, multi-center study to document the efficacy, safety and tolerability of long-term administration of RO0503821 in patients with chronic renal anemia.
GD33-199-301 Genzyme Study (2005-2008). A Randomized, Parallel, Open-label study to compare once per day Sevelamer Carbonate Powder Dosing with Three Times Per Day Sevelamer Hydrochloride Tablet Dosing in Chronic Kidney Disease Patients on Hemodialysis.
CERA ML20336 Time and Motion Study (2006-2008). A prospective, Randomized, open-label, multi-center, pharmacoeconomic evaluation (Time and Motion) comparing RO0503821 to epoetin alfa in patients with chronic kidney disease (CKD) stage V on dialysis.
EMERALD Afdfymax-12 (2006-2008). A Phase 3 Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of AF37702 Injection for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated with Epoetin alfa.
PEARL Affymax-11 (2006-2008). A Phase 3 Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of AF37702 Injection for the Correction of Anemia in Patients with Chronic Renal Failure (CRF) not on Dialysis and not on Erythropoiesis Stimulating Agent (ESA) Treatment.
Ikaria-Carbon Monoxide (2008) for Inhalation. (Protocol C201). A single-blind, placebo-controlled, safety and tolerability study of the effects of carbon monoxide for inhalation in patients receiving kidney transplants.
CTOT-02 (2008) - B-Cell Depletion by Anti-CD20 (Rituximab) in Renal Allograft Recipients Who Develop de novo Anti-HLA Alloantibodies Will Result in Inhibition of Alloantibody Production and Attenuation of Chronic Humoral Rejection.
Everolimus - RAD001H2304 (2008) - Everolimus (RAD) 24 montth, multi-center, open-label, randomized, controlled study to evaluate the efficacy and safety of concentration-controlled everolimus to eliminate or to reduce tacrolimus compared to tacrolimus in de novo patients.
QRK.006 (2008) - Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study of the Safety, PK, and Clinical Activity of I5NP for Prophylaxis of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation.
Tacro 2017 (2008) - A Phase II, open-label, multi-center, randomized trial to compare the pharmacokinetics of LCP-Tacro tablets Once-A-Day to Prograf Capsules Twice-a-Day in de Novo Kidney transplant patients.
Tacro 3001 (2008) - A Phase 3 Open-label, Multicenter Prospective, Randomized Study of the Efficacy and Safety of Conversion from Prograf® Capsules Twice Daily to LCP-Tacro™ Tablets Once Daily for the Prevention of Acute Allograft Rejection in Stable Kidney Transplant.