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Renal Insufficiency clinical trials

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NCT ID: NCT01312064 Terminated - Renal Insufficiency Clinical Trials

De Novo Everolimus-based Therapy for Renal Transplantation Using Rituximab Induction

Start date: April 2011
Phase: Phase 4
Study type: Interventional

The investigators hypothesized that everolimus-based immunosuppressive therapy combined with rituximab induction could provide comparable safety profiles for renal transplant patients, as compared to standard immunosuppressive therapy using thymoglobulin induction, tacrolimus, mycophenolate mofetil and steroids, in terms of acute rejection rate and renal function. Rituximab was reported to reverse refractory acute kidney transplant rejection. Combined with immunoadsorption with or without IVIG, rituximab could successfully prevent antibody-mediated rejection in ABO-incompatible renal transplantation. This study is to assess whether a CNI-free regimen including B-cell depleting antibody induction, everolimus and MMF results in comparable long-term function without a negative impact on safety or efficacy of immunosuppression. This study will be open-label and two-arm randomized (2:1).

NCT ID: NCT01286506 Terminated - Critical Illness Clinical Trials

Observational Study of Blood Pressure Measurements and Continuous Dialysis

Start date: February 2011
Phase: N/A
Study type: Observational

Dialysis is used to control the fluid balance and metabolic state of patients with kidney disease. Control of the metabolic state, via electrolytes, can be monitored using labs that are routinely drawn from patients undergoing continuous hemodialysis. Control of fluid removal is much more difficult. This study aims to determine whether changes in the blood pressure associated with breathing correlate with or predict intolerance to fluid responsiveness with continuous dialysis. We hypothesize that a measurement of changes in blood pressure with breathing called arterial pulse pressure variation may be able to predict the ability to remove fluid during continuous renal replacement therapy.

NCT ID: NCT01278758 Terminated - Metastatic Cancer Clinical Trials

A Dose-escalation Pharmacokinetic Study of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and Patients With Normal Renal Function

Start date: March 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and pharmacokinetics of ASA404 in patients with refractory or relapsed metastatic cancer with impaired renal function and with normal renal function. It is very possible that patients with renal impairment will show differences in renal excretion of parent ASA404 and its metabolites, warranting a study that leads to a better pharmacokinetic assesssment in this population.

NCT ID: NCT01240642 Terminated - Clinical trials for Metastatic Cancer With Normal Renal Function

An Open-label, Dose Escalation Multi-center Study in Patients With Advanced Cancer to Determine the Infusion Rate Effect of ASA 404 With Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokietics of Free and Total ASA404

Start date: January 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the effect of the ASA404 infusion rate and co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on the pharamcokinetics (PK) of free and total ASA404.

NCT ID: NCT01230489 Terminated - Renal Failure Clinical Trials

The Efficacy of "MediHoney" to Facilitate Catheter Exit-Site Surgical Wound Healing

Start date: January 2011
Phase: N/A
Study type: Interventional

To evaluate the efficacy of honey as a post surgical exit site care process to promote healing and prevent infectious bacterial colonization of newly created exit sites. It has been shown in the medical literature that honey has properties that are conducive to healing and the prevention of infection. In one study it was demonstrated that in urethral injury in the rat treated with honey the injury healed with none of the usual formation of fibrous tissue seen in such healing processes, that there was no reduction in the luminal diameter usually seen, and that the cells lining the urethra were uncompromised in any way, i.e. totally normal and healthy. We feel that if an exit site can be healed quickly with good normal tissue being developed that the patient will have a much better chance to keep that exit healthy reducing time, cost, and disruption of lifestyle. Other positive aspects of honey are it has the low pH required for good healthy tissue healing, it works in the presence of wound fluids, and it has never been shown to produce a resistant bacterial strain.

NCT ID: NCT01225458 Terminated - Aged Clinical Trials

Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

BCDE
Start date: July 2008
Phase: N/A
Study type: Interventional

The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly patients aged over 75 years with renal insufficiency stage 5 will be included in the study after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in the "exclusive nephrology follow-up" arm will continue their usual follow-up; 250 patients in the "geriatric follow-up" arm will have both their usual nephrology follow-up and a geriatric follow-up. The aim of the study is to determine if a systematized gerontologist evaluation delay the occurrence of a composite primary endpoint : death, dementia, depression and severe dependency. The hypothesis is that the functional and vital prognosis of a patient with renal insufficiency depends not only on common and classical factors but also on cognitive and psychological functions and dependence, particularly in elderly patients.

NCT ID: NCT01223755 Terminated - Clinical trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Sirolimus In Autosomal Dominant Polycystic Kidney Disease And Severe Renal Insufficiency

SIRENA-II
Start date: September 2010
Phase: Phase 2/Phase 3
Study type: Interventional

The general aim of this study in adult patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and severe renal insufficiency is to assess the safety and the efficacy of sirolimus (SRL) in slowing renal function decline as compared to conventional therapy.

NCT ID: NCT01163799 Terminated - Clinical trials for Transplant; Failure, Kidney

A Pilot Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients

Start date: July 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess Alefacept in combination with alemtuzumab induction and calcineurin inhibitor and corticosteroid withdrawal.

NCT ID: NCT01104662 Terminated - Renal Impairment Clinical Trials

Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment

RENSE
Start date: April 19, 2010
Phase: Phase 4
Study type: Interventional

This is a multicenter, randomized, evaluator-blinded, comparator-controlled study. Participants were to be randomized (1:1) to daptomycin or comparator, stratified by degree of renal impairment (creatinine clearance [CLcr] 30 - 50 milliliters per minute [mL/min] [moderate impairment] and <30 mL/min [severe impairment]) and by type of infection (bacteremia and complicated skin and skin structure infections [cSSSI]) to create 4 cohorts defined as follows: - Cohort 1: Bacteremia and CLcr <30 mL/min - Cohort 2: Bacteremia and CLcr 30 - 50 mL/min - Cohort 3: cSSSI and CLcr <30 mL/min - Cohort 4: cSSSI and CLcr 30 - 50 mL/min Participants will be treated and evaluated for safety and microbiological and clinical efficacy in accordance with their type of infection and degree of renal impairment. Peak and trough samples will be collected to assess exposure to daptomycin for participants on Day 1 and following the 5th dose.

NCT ID: NCT01067963 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Self-Management and Resourceful Transition of Type 2 Diabetes With Stage 3 Kidney Disease

SMaRT
Start date: December 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to establish the usefulness and the impact of a tailored behavioral-education and counseling intervention titled Self-Management and Resourceful Transition (S.M.a.R.T) among patients with type 2 diabetes mellitus and stage 3 chronic kidney disease, in order to help them to manage their behaviors related to their condition and health.