A Phase IIIb Study to Evaluate the Safety and Efficacy of Gemigliptin in Type 2 Diabetes Mellitus...
Type 2 DM Patients With Moderate or Severe Renal ImpairmentTherapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor gemigliptin in patients with type 2 DM and moderate or severe renal impairment for long-term peirod (52 weeks).
IVUS Guidance to Reduce Contrast in Coronary Angioplasty
Contrast Media ReactionAcute Renal FailureThis study tests the hypothesis that ultrasound-guided PCI reduces contrast volume during the procedure.
Pharmacokinetics Study of AMG 423 in Healthy Subjects and Subjects With Various Degrees of Renal...
Heart FailureA phase 1, open-label study in subjects with normal renal function and subjects with various degrees of renal insufficiency, including patients with end-stage renal disease (ESRD) requiring hemodialysis. The primary objective is to evaluate the single-dose PK of AMG 423 in subjects with various degrees of renal insufficiency, including patients with end-stage renal disease requiring hemodialysis.
A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis...
Chronic Kidney DiseaseRenal Insufficiency1 moreThis is a randomized, double blind, placebo-controlled multi-center study to examine the efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not on dialysis.
Optimising Renal Outcome in Myeloma Renal Failure
Multiple MyelomaChronic Kidney DiseaseThe purpose of this study is to compare the effectiveness of bortezomib versus thalidomide in reducing free light chains in the blood of myeloma patients. In addition participants will receive bendamustine (chemotherapy) and dexamethasone (steroids), which increase the effectiveness of both bortezomib and thalidomide. The trial will also study whether an earlier reduction of free light chains increases the chances of the kidneys recovering.
Treatment of Obstructive Sleep Apnea in Chronic Kidney Disease
Sleep ApneaObstructive2 moreThis study is being conducted to determine whether treatment of obstructive sleep apnea (OSA) in patients with chronic kidney disease (CKD) improves kidney function. Half of the participants will receive continuous positive airway pressure (CPAP) treatment for their OSA in addition to their regular CKD treatment, while the other half will only receive their regular CKD treatment.
Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin...
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 15 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 3 hospitals in the UK. Bayer HealthCare AG is funding this research.
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of...
DiabetesDiabetes Mellitus2 moreThis trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide in subjects with various degrees of impaired renal function compared to subjects with normal renal function.
Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients...
Renal InsufficiencyChronicThe study to be conducted is a prospective, open label trial. It is designed to evaluate the pharmacokinetic/pharmacodynamic and coagulation parameters and safety of dabigatran etexilate in patients with chronic kidney disease.
Study of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired...
Impaired Renal FunctionShire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias. The primary purpose of the study is to assess the pharmacokinetics of SSP-004184 (FBS0701) following a single 75mg/kg dose of SSP-004184 (FBS0701) in healthy adults and elderly subjects and in adult subjects with mild, moderate, severe, and end stage renal disease (ESRD) degrees of impaired renal function. The results of this study will characterize the pharmacokinetics, safety, and tolerability of SSP-004184 (FBS0701) in adult subjects with various degrees of renal impairment, and these data will be compared to healthy adult and elderly subjects.