View clinical trials related to Renal Insufficiency.
Filter by:The purpose of this study is to demonstrate non-inferiority of an advagraf based immunosuppressive regimen with slower dose tapering and lower starting dose of Advagraf compared with a standard Advagraf-based immunosuppressive regimen in de novo renal transplantation. Non inferiority will be assessed by a combined study endpoint consisting of the development of biopsy-proven rejection of BANFF class Ia or higher and/or graft loss and/or patient death within the first six months after renal transplantation.
In this multi-center, randomized, double-blind, active-controlled, phase II non-inferiority study, we aimed to test the non-inferiority of evogliptin vs linagliptin in terms of reduction of albuminuria at week 24 from baseline in patients with type 2 diabetes having renal insufficiency.
This study is a phase 1 non-randomized, open-label, single-dose, parallel-group study of PF 04965842 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with moderate renal impairment (Part 2).
The purpose of the study is to identify predictors of treatment response. This involves collected baseline clinical parameters and bloods for biochemical parameters prior to administering the study treatment. A positive outcome following treatment was defined as an uptitration of haemoglobin by greater than 5g/l within 2 months. The study evaluated the participants response to treatment against the clinical and biochemical information collected prior to treatment being received.
This is an open-label, non-randomized, successive cohorts design, multicenter, single dose phase I study. The primary objectives are: - to evaluate the pharmacokinetics (plasma and urine) profile of P03277 following single intravenous injection (0.1 mmol/kg body weight) in patients with mild to severe renal impairment and in healthy volunteers with normal renal function used as reference. - to assess dialysability of P03277 following a single intravenous injection (0.1 mmol/kg body weight) in patients with end stage renal disease requiring hemodialysis.
The investigators propose to conduct a nationwide (Nigeria), prospective, non-interventional cohort study describing the clinical course, biological characteristics, case management and outcomes in patients hospitalized for a suspected or confirmed diagnosis of Lassa fever in tertiary medical facilities situated in the most affected Nigerian states. Special focuses will be made on situations at risk of bad outcome such as pregnancies, acute kidney injury and electrolytic imbalance in patients with confirmed Lassa fever. Participants for which the diagnosis of Lassa fever will be finally excluded by reverse-transcriptase polymerase chain reaction (RT-PCR) will constitute the control group.
End-stage renal disease patients undergoing hemodialysis can present alteration in flow, concentrations and composition of saliva affecting oral health. This randomized placebo-controlled trial aims to evaluate the effectiveness of photobiomodulation therapy (PBM) in salivary parameters in chronic renal failure (CRF) patients undergoing hemodialysis. Forty-four patients with CRF on hemodialysis self-responded two questionnaires for oral health and salivary gland function perception. Thereafter, patients were clinically evaluated for the diagnosis of hypofunction of salivary glands and were randomly allocated into two groups: PBM group (n = 21), which received three irradiations of laser at ʎ = 808 nm, 100 mW, 142 J/cm2 and 4 J per point; and a placebo group (n = 17) that consisted of laser protocol with the device switched off. Patients were first submitted to sialometry and after to PBM or placebo intervention at baseline, 7 and 14 days. Non-stimulated and stimulated saliva were collected for salivary volume investigation and biochemical analysis of total protein, calcium and urea concentrations.
The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD). The InnAVasc AVG is implanted and used similar to other standard of care dialysis grafts currently on the market. However, the InnAVasc AVG has been uniquely designed to potentially allow for immediate needle access (same day as implant surgery as opposed to 2-4 weeks of waiting), to potentially reduce excessive bleeding from the graft after dialysis, and it may provide protection from improper or missed needle cannulation attempts.
Diabetes after kidney transplantation is a frequent complication, the incidence of which varies from 7 to 45% depending on the studies and on the diagnostic criteria used. Post-transplant diabetes is an early complication, most often occurring in the first month after transplantation. In addition to the additional health costs generated by the appearance of post-transplant diabetes, the risk of graft loss is increased by 60% and the overall mortality risk by 90%. Similarly, the development of glucose intolerance after transplantation is associated with higher mortality. Tacrolimus treatment is therefore currently one of the most important risk factors for diabetes at the time of transplantation. Indeed, several in vitro and in vivo animal studies have shown that tacrolimus alters pancreatic endocrine function. In the final stage, this cellular toxicity leads to diabetes, most often diagnosed on the rise in capillary or venous blood sugar levels after transplantation. This diabetes often requires hypoglycemic treatment with insulin or oral anti-diabetic drugs. for a variable period. The pro-diabetogenic effect of tacrolimus is sometimes irreversible, justifying preventive treatment. No clinical studies have looked at "sub-clinical" changes in insulin secretion or insulin resistance under tacrolimus prior to the onset of diabetes. The static indices HOMA-β% and HOMA-IR (Homeostasis Model Accessment of insulin resistance) make it possible to estimate insulin secretion and insulin resistance in fasting patients respectively, while the oral glucose disposition index (IDO) makes it possible to study insulin secretion and action dynamically (after a 75 g glucose load), and are calculated as follows: HOMA IR= Fasting blood glucose (mmol/L) x Fasting insulin (mU/L)/ 22.5 HOMAβ% = 20 x fasting insulinemia (mU/L) / fasting plasma glucose (mmol/L) - 3.5 IDO = (delta insulinemia T30-T0/ delta blood glucose T30-T0)/insulinemia T0 These indices have already been studied in dialysis patients (diabetic and non-diabetic) and may allow a more detailed study of pancreatic response and insulin resistance under tacrolimus in patients prior to renal transplantation. Determining the "pancreatic response" to tacrolimus in patients prior to transplantation would prevent diabetes by adapting immunosuppressive treatment and post-transplant screening modalities in the event of pre-transplant subclinical abnormalities identified in our study. The development of tacrolimus-induced diabetes in pre-transplantation in our study will be a contraindication to tacrolimus at the time of transplantation and ciclosporin therapy will be preferred.
This was a multicenter study of the pharmacokinetics (PK) of melphalan during treatment with melflufen and dexamethasone in patients with relapsed refractory multiple myeloma (RRMM) and impaired renal function.