Gambro AK200 ULTRA Hemodiafiltration Study
Chronic Renal FailureThis study is designed to assess the safety, efficacy and dialytic capabilities of hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA in comparison to conventional hemodialysis.
A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009)
Chronic Renal InsufficiencyType 2 Diabetes MellitusThis is a 2-part study in participants with renal impairment and matched healthy participants to investigate the effect of impaired renal function on the plasma and urine levels of omarigliptin (MK-3102) after taking a single 3 mg dose by mouth.
Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe...
Autosomal Dominant Polycystic Kidney DiseaseThe general aim of the trial is to assess the efficacy of one year treatment with long-acting somatostatin analogue (Octreotide LAR) compared with placebo in slowing kidney and liver growth rate in patients with ADPKD and moderate/severe renal insufficiency and to assess whether and to which extent this translates into slower renal function decline over 3-year follow-up.
A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen)...
Chronic Kidney DiseaseChronic Renal FailureThe purpose of this study is to demonstrate therapeutic equivalence of IV Epoetin Hospira compared to IV Epogen (Amgen), based on maintenance of Hb levels and study drug dose requirements in patients treated for anemia associated with chronic renal failure and on hemodialysis.
A Pharmacokinetics and Safety Study in Subjects With Renal Impairment
Renal ImpairmentThe purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of TR701 FA in subjects with advance renal impairment.
An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer...
Unspecified Adult Solid TumorProtocol SpecificThis is an open-label non-randomized study in subjects with advanced or metastatic solid tumors who are no longer responding to available therapy. HALAVEN will be administered to subjects on Days 1 and 8 of a 21-day cycle.
Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients
Kidney FailureSecondary Hyperparathyroidism1 moreThis is a pilot, prospective randomized controlled study with the primary objective to evaluate and compare medical treatment of severe SHPT, namely oral cinacalcet versus surgical treatment, that is, parathyroidectomy with forearm autografting, on the progression of coronary artery and valvular calcification and left ventricular mass index in endstage renal disease patients receiving peritoneal dialysis over 12 months. The change in arterial stiffening, left ventricular volume, aortic valve calcium score and bone mineral density, nutritional status and biochemical parameters, quality of life measures will be evaluated as secondary objectives of this study.
15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)
AnemiaRenal Insufficiency1 moreAnaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin. The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease. The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 14 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests. The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this research.
Belatacept 3 Month Post Transplant Conversion Study
Transplant; FailureKidney1 moreThis study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months after kidney transplantation. The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking the transplanted organ. The primary purpose of this research study is to evaluate the effects of three (3) different immunosuppressive treatments on rejection in post-transplant kidney recipients. This study will test whether switching from tacrolimus to belatacept will improve long-term kidney function. Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug Administration (FDA) to be used after transplant. All of these medications have been routinely used in kidney recipients here at Northwestern University. Belatacept (the "study drug") has been approved by the FDA for use at the time of transplant. However, the use of belatacept in this study is considered investigational as it has not been FDA approved for use beginning at 3 months after transplant. This study will involve 51 adult kidney transplant recipients at Northwestern.
An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus...
Diabetes MellitusType 21 moreThe purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have reduced kidney function.