
Study of the Effect of Synchronised Anaemia Management in Chronic Kidney Disease
Kidney FailureChronic1 moreAims: To establish an electronic process for CKD anaemia management using monthly synchronized dosing of erythrocyte stimulating agents (ESA). To compare this electronic process with "present anaemia management" in the traditional outpatient setting. To monitor Hb targets and clinical endpoints of study groups to model a larger multicentre study focusing on these endpoints.

Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate
Kidney Failure,ChronicThis study is to evaluate the effectiveness and safety of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate, investigate the proper dialysis dose for Chinese CAPD patients.

Afatinib in Subjects With Kidney Dysfunction
Renal InsufficiencyThe primary objective of the current study is to investigate the influence of moderate to severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in comparison to a control group with normal renal function. The assessment of safety and tolerability will be an additional objective of this trial and will be evaluated by descriptive statistics.

Infusion of T-Regulatory Cells in Kidney Transplant Recipients (The ONE Study)
Kidney FailureKidney TransplantThis research study is for patients who are going to receive a kidney transplant from a living donor. After kidney transplantation, it is necessary for transplant recipients to take "immunosuppressive drugs". These drugs work by preventing the body's immune cells from attacking and "rejecting" the new kidney. Taking these drugs long-term may also cause harm to the transplanted kidney. Therefore, the transplant community is very interested in finding ways to decrease immunosuppressive drug treatment and further reduce the risk of kidney rejection. One method to do so is known as "induction of tolerance", which is when the person who receives a transplant has treatment to make their immune cells tolerant to the donor cells. In this study, we will try to induce tolerance by mixing recipient cells and their donor's cells together with belatacept, an immunosuppressive drug. Belatacept is a protein that attaches to immune system cells, interferes with the immune response and results in tolerance induction. After we mix the recipient cells with the donor's cells, we will sort out one particular kind of immune cell, called a regulatory T cell, and inject them back into the recipient. Regulatory T cells are the cells that are affected by induction to reduce rejection of donated organs. This method for inducing tolerance has been used in bone marrow transplantation, but this is the first time it is being done in kidney transplantation. This study is being conducted as part of a unique collaboration of US and EU centers called The ONE Study. The ONE Study centers have agreed to work together using common protocols and procedures but with each testing their own regulatory population for safety and the ability to promote kidney survival. Sharing data among the participating sites will permit a deeper understanding of how and why some treatments might succeed while others work less well.

Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency...
HCV InfectionThe primary objectives of this study are to evaluate the safety and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) for 24 weeks and ledipasvir/sofosbuvir (LDV/SOF) for 12 weeks, and to evaluate the steady state pharmacokinetics (PK) of SOF and its metabolites and LDV in participants with genotype (GT) 1, 3, or 4 hepatitis C virus (HCV) infection who have chronic renal insufficiency (impaired kidney function).

A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients...
Chronic Renal FailureThis is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume of at least 500 mL/day.

Anti-inflammatory Effect of Atorvastatin on Graft Donor Kidney
Renal InsufficiencyRenal Insufficiency is a priority disease in health system, which may require renal replacement therapy based on renal transplantation, which is considered as therapy of choice. During the procedure of renal transplantation, the graft could be damaged by ischemia-reperfusion which generates complications in its function. Recently the anti-inflammatory and immunomodulatory effects of statins have been emphasized, which could be beneficial in renal transplantation.

Clinical Study of Asahi ViE Dialyzer in Canada
Kidney FailureChronicThe purpose of the study is to obtain performance data on the Asahi ViE-21 dialyzer (ViE-21) .

A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine...
Advanced Urothelial CancerMetastatic Urothelial CancerThis is a phase II/III, multicenter, randomized study which includes 420 patients on six years + 3 years follow up. 92 patients will be included during the phase II ; additional 328 patients will be included. Patients with an advanced or metastatic urothelial cancer with impaired renal function will be randomized in one of the two following chemotherapy arm: Fractionated Cisplatin + Gemcitabine. Carboplatin + Gemcitabine. The main objective of the part II study will be to evaluate the efficacy and the safety of a chemotherapy with a doublet platinum salt compound/Gemcitabine with fractionated Cisplatin or Carboplatin in this population. The main objective of the part III study will be to compare the efficacy in terms of overall survival of a chemotherapy with a doublet platinum salt/Gemcitabine with fractionated Cisplatin or Carboplatin in this population.

iChoose Decision Kidney Aid for End-Stage Renal Disease Patients
End-Stage Kidney DiseaseKidney Failure2 moreThe investigators developed iChoose Kidney -- a shared decision-making support tool accessible through iPad, iPhone, or the web -- to provide ESRD patients and their providers with a simple, standardized, easily accessible, statistically robust tool for use in the clinic to guide patient education and healthcare decision-making about treatment options of dialysis or kidney transplantation. The iChoose Kidney decision aid provides patients with estimates of their individualized 1 and 3-year risks of mortality on dialysis vs. transplantation, based on previous national data. The tool has the potential to improve communication and decision-making between patients and their healthcare providers and improve access to kidney transplantation among patients with ESRD. This will be a two-arm, randomized study, and will be conducted at 3 large transplant centers with diverse patient populations. One group of patients will receive standard education alone during their scheduled transplant evaluation. The second group will receive the standard education as well have the provider use the iChoose Kidney aid with them. The project timeline will be a total of 24 months inclusive of enrollment, follow-up, data analysis, and outcome evaluation. This study will assess how well the iChoose decision aid works in improving patient knowledge, preferences for treatment, and patient access to transplant. The study will also assess whether providers find the tool useful for providing ways to share information with patients about ways to treat their kidney disease.