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Renal Insufficiency clinical trials

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NCT ID: NCT02278159 Completed - Clinical trials for Kidney Failure, Chronic

Evaluation of the Integrated Home Dialysis Model

Start date: January 2000
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate which home dialysis modality pattern (home hemodialysis [HHD], peritoneal dialysis [PD] or a combination of both, e.g. PD and then HHD) allows for the longest home dialysis survival, as defined by the time dialysed in a home environment. The investigators hypothesize that patients transferred from one home modality to another will have a longer home dialysis survival compared to patients treated only with PD or HHD.

NCT ID: NCT02275156 Completed - Hyperlipidemia Clinical Trials

Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab

Start date: August 19, 2014
Phase: Phase 1
Study type: Interventional

The primary objective of this study was to evaluate the pharmacokinetics of evolocumab after a single 140 mg subcutaneous (SC) dose in aduts with normal renal function or severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis.

NCT ID: NCT02266979 Completed - Clinical trials for Chronic Renal Failure

Study to Determine Appropriate Nurse: Patient Ratios in Peritoneal Dialysis Programs

Start date: June 2014
Phase: N/A
Study type: Observational

As the resolution of the Brazilian Federal Council of Nursing (COFEN) sizing the framework of nursing professionals is essential to ensure the safety and quality of patient care. To achieve such goals actions are needed to evaluate the variety of tasks and performance specific to each area in nursing profession. The National Agency for Health Surveillance (ANVISA), through Board Resolution (RDC-154) determines that the nurse to patient ratio is 1 to 30 in hemodialysis and 1 to 50 on peritoneal dialysis, however these targets are not based on any evidence, and same apply to other Latin-American countries. Objective: To determine the appropriate nurse: patient ratio for peritoneal dialysis unit. Method: This research will be developed in two phases. The first with an observational design with descriptive and qualitative approach. There will be a focus group with experts in the field, to defined the activities and responsibilities of the peritoneal dialysis nurse, and produce a tool with a list of activities. A time-orientated score will be created. In the second stage a cross-sectional quantitative approach will be used. To apply the instrument from by direct observation of activities performed by nurses during their workday. With the instrument activities will be timed and the overall time of each nursing activity will be determined by multiplying the time spent by the total number of patients. It is expected tat this strategy will increase time on treatment and/or decrease dropout rates, by developing an easy test/ formula application to determine the correct ratio according to the peritoneal dialysis program. This tool will provide better outcomes for patients as well as allow for growth of peritoneal dialysis programs with qualified assistance and patient safety.

NCT ID: NCT02263820 Completed - Acute Kidney Injury Clinical Trials

Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography

NORDICA
Start date: January 2015
Phase:
Study type: Observational

Contrast-induced acute kidney injury (CI-AKI) has been recognized as the third most common cause of hospital acquired AKI, after hypotension-associated hypo-perfusion and post-operative AKI. The development of CI-AKI after cardiac catheterization is associated with a significant increase in both short-term and long-term mortality and morbidities, as well as an increase in length of stay and cost. The only marker of renal function that has predictive ability is creatinine and it has significant limitations in identifying patients who will develop AKI. Therefore, a diagnostic test for predicting CI-AKI risk would have widespread clinical utility. The primary purpose of this study is to measure the association between baseline expression of senescence markers in blood using SenesceTest and the occurrence of CI-AKI post cardiac catheterization.

NCT ID: NCT02254070 Completed - Healthy Clinical Trials

Influence of Different Degrees of Renal Impairment on the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BIBT 986 BS in Subjects With Normal Renal Function and Patients With Different Degrees of Renal Impairment

Start date: June 2003
Phase: Phase 1
Study type: Interventional

To assess the influence of different degrees of renal impairment on safety, tolerability, pharmacodynamics and pharmacokinetics of 1.0 mg of BIBT 986 BS given as a single dose infusion over 30 minutes in comparison to a normal renal function

NCT ID: NCT02253654 Completed - Anemia Clinical Trials

Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis

Start date: April 1, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare two different dosing methods of epoetin alfa and their effectiveness in maintaining hemoglobin levels between 10.0 to 11.0 g/dL in in patients with chronic kidney disease (CKD) receiving hemodialysis.

NCT ID: NCT02252055 Completed - Clinical trials for Renal Failure, End Stage

The ONE Study ATDC Trial

ONEatDC
Start date: March 19, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

To collect evidence of the safety of administering autologous tolerogenic dendritic cells (ATDC) preparations to living-donor renal transplant recipients in the context of an international European Union funded consortium aimed at evaluationg cellular immunotherapy in solid organ transplantation (The ONE Study). It is anticipated that immune regulation induced by ATDC therapy can evntually be used to reduce the need for conventional immunosuppression in transplant recipients.

NCT ID: NCT02250235 Completed - Clinical trials for Kidney Failure, Chronic

Piloting an Intervention for Improving Treatment Adherence

Start date: November 2012
Phase: N/A
Study type: Interventional

Helping patient with long-term conditions to make informed decisions about adherence to their treatment is an important element in facilitating self-management. Estimates of non-adherence to treatment in people living with long-term conditions are typically high, averaging at around 50%.This not only impacts negatively on patient outcomes but also places a significant financial burden on healthcare provision. While clinical efforts have focused on promoting patient self-management, with some success, work in Psychology on behaviour change has had little influence on clinical practice. In this project, the team wish to evaluate the potential for a novel intervention from the behaviour change literature, self-affirmation, to promote improved fluid control among non-adherent patients. The intervention works by promoting a patient's sense-of-self (self-affirmation), which has been shown to modify the patient's acceptance of health-risk information, their self-efficacy, their intention to change, and subsequently their behaviour. A randomised controlled pilot trial is proposed. The trial is designed to build upon routine education about fluid control during dialysis visits, and will compare a group of patients who have received an intervention to boost their sense-of-self (self-affirmation arm) to a control group (control arm). Patients in the self-affirmation arm should have a more positive evaluation of the health-risk information about fluid management, feel more able to, and intend to change their fluid control behaviour, and subsequently have lower interdialytic weight gain.

NCT ID: NCT02244762 Completed - Renal Impairment Clinical Trials

Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) in Subjects With Renal Impairment

Start date: February 2011
Phase: Phase 1
Study type: Interventional

Determine the influence of renal impairment on the pharmacokinetics and metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules

NCT ID: NCT02240017 Completed - Clinical trials for Metastatic Urothelial Cancer

A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function.

VEFORA
Start date: January 21, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This 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.