Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity...
AnemiaChronic Renal InsufficiencyThis is a randomized, controlled, double-blind, multicenter multinational safety study involving about 300 predialysis patients aged 18 years or above suffering from anemia. Symptomatic anemia will be corrected by s.c. application of EPO HEXAL or ERYPO® in order to achieve a hemoglobin target range of 10.0 -12.0 g/dL.
The Effect of Isoflurane or Sevoflurane on Kidney Function
Kidney FailureThe purpose of this study is to determine if isoflurane and sevoflurane have similar effects on the kidneys of people with impaired kidneys when the drugs administered with low gas flow into anaesthetic machines.
Study of the Use of Niaspan for Treatment of Dyslipidemia in Diabetic Nephropathy
Diabetes MellitusType 23 moreThe primary purpose of this study is to test the effectiveness and tolerability of Niaspan® to improve the levels of blood fats ("good" and "bad" cholesterol and triglyceride levels) in people who have kidney damage due to diabetes. A secondary goal is to test whether Niaspan® slows down further development of kidney damage.
Eliminating the Need for Pancreas Biopsy Using Peripheral Blood Cell-free DNA
Transplant;Failure,KidneyTransplant; Failure3 moreDonor-derived cell-free DNA (dd-cfDNA) has shown promise as an early marker for cellular injury caused by rejection. dd-cfDNA changes may also indicate other injuries that lead to progressive decline in transplant organ function associated with, in the case of kidney transplantation, the presence of interstitial fibrosis (IF) and tubular atrophy (TA) seen in biopsy specimens. Here, we will study the utility of dd-cfDNA to predict rejection in pancreas and pancreas-kidney recipients.
BEACH Trial: Bovine Early Access, Compatibility and Hemostasis Trial
Renal Insufficiency,ChronicBovine Early Access, Compatibility, and Hemostasis (BEACH) Trial Study is to evaluate the Safety and Effectiveness of Early Access in Patients Who Require an Arteriovenous Conduit for Hemodialysis using the Artegraft® Collagen Vascular Graft™. The objective of the BEACH Trial is to demonstrate that early access of Artegraft is associated with acceptable rates of successful early access, and acceptable rates of a composite of adverse events, to support a modification of existing device labeling stating that Artegraft is capable of cannulation within 72 hours post implantation.
Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease
Diabetic Kidney DiseaseDiabetic Nephropathies8 moreThe Researchers will assess the safety, tolerability, dosing effect, and early signals of efficacy of intra-arterially delivered autologous (from self) adipose (fat) tissue-derived mesenchymal stem/stromal cells (MSC) in patients with progressive diabetic kidney disease (DKD).
Kidney Precision Medicine Project (KPMP) - COVID-19 Protocol
Acute Kidney FailureAcute Kidney Insufficiency13 moreSince its inception, KPMP has developed sophisticated protocols for collection and analysis of human kidney tissue, and for collection of biofluids. Members of the consortium have wide-ranging expertise in conducting clinical studies, processing kidney tissue, advanced structural and molecular analysis and complex bioinformatics analysis, which will be used to leverage effectively as a group to better understand kidney disease. This joint protocol aims to synergize the COVID-19 study efforts of KPMP academic research centers, to collectively study COVID-19, including its renal presentation using kidney tissue and/or biofluids from patients suffering from COVID-19. This will increase the breadth and depth of data available to the public to expedite discoveries, identify therapeutics, and improve outcomes for patients with COVID-19. It will additionally bring the expertise of KPMP investigators to bear against this pandemic.
Evaluate Safety and Pharmacokinetics of Minocin (Minocycline) for Injection in Subjects With Renal...
Renal InsufficiencyAcute3 moreThis is a Phase 1, open-label, single-dose study of the safety, tolerability, and pharmacokinetics of Minocin® (minocycline) for injection in subjects with renal insufficiency.
A Phase 1 Study to Assess the Effect of Severe Renal Impairment on the Pharmacokinetics, as Well...
Severe Renal ImpairmentThe purpose of this study is to assess the effect of severe renal impairment on the steady-state PK, as well as safety and tolerability, of ranolazine, compared to subjects with normal renal function.
Kidney Function in Sickle Cell Anemia
Sickle Cell DiseaseKidney Failure1 moreThis is a prospective clinical cohort study that involves a baseline study visit followed by up to 3 annual follow-up study visits for a total follow-up of 36-48 months to evaluate the age- and sex-adjusted rate of change in kidney function, and to identify biomarkers of endothelial function, metabolomic profiles and clinical characteristics for the worsening of kidney function and for a rapid decline in kidney function. "Funding Source - FDA OOPD"