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Renal Insufficiency clinical trials

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NCT ID: NCT01152411 Active, not recruiting - Clinical trials for Chronic Renal Failure

Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Chronic Renal Failure

Start date: February 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Chronic renal failure (CRF, or "chronic kidney failure", CKF, or "chronic kidney disease", CKD) is a slowly progressive loss of renal function over a period of months or years and defined as an abnormally low glomerular filtration rate, which is usually determined indirectly by the creatinine level in blood serum. CRF that leads to severe illness and requires some form of renal replacement therapy(such as dialysis) is called end-stage renal disease (ESRD). While renal replacement therapies can maintain patients indefinitely and prolong life, the quality of life is severely affected. Renal transplantation increases the survival of patients with stage 5 CKD significantly when compared to other therapeutic options; however, it is associated with an increased short-term mortality (due to complications of the surgery). In view of the above, there is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully hence the inadequacy of current treatment modalities and insufficiency of donor organs for transplantation have driven a search for improved methods of dealing with renal failure. The rising concept of cell-based therapeutics has provided a framework around which new approaches are being generated, and its combination with advances in stem cell research stands to bring both fields to clinical fruition. Since CRF affects a large number of these patients who will lose their productive life, stem cell implantation can offer some promise of improved health. In our present study, we want to evaluate the safety and efficacy (to know / observe for Proof of concept in five indian patients) if any, of autologous bone marrow derived stem cells injected into the Renal Artery in five (initially five patients, can be increased to ten patients after observing the initial results) patients with Chronic Renal Failure.

NCT ID: NCT01148368 Completed - Renal Impairment Clinical Trials

A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers

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

The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in renal impairment patients and healthy volunteers.

NCT ID: NCT01146353 Withdrawn - Influenza Clinical Trials

Pharmacokinetic Assessment of Peramivir in Hospitalized Adults Undergoing Continuous Renal Replacement Therapy

Start date: February 2010
Phase:
Study type: Observational

Pharmacokinetics for peramivir have not been well characterized in patients undergoing continuous renal replacement therapy CRRT - either Continuous veno-venous hemofiltration (CVVH) +/- dialysis (CVVHD). CRRT is commonly utilized in the hospital setting for patients with acute kidney injury for metabolic correction, slow continuous fluid removal, and to maintain hemodynamic stability. CRRT commonly alters drug disposition and clearance, and dosing regimens often need alteration in patients receiving CRRT. Doses required to generate predictable serum concentrations can be calculated from known patient parameters such as replacement fluid and dialysate flow rate, sieving coefficients, and desired serum concentrations. However, pharmacokinetic studies must be performed in CRRT patients to generate drug removal constants or sieving coefficients. Of note, the clearance of drugs by conventional hemodialysis cannot be used to extrapolate clearances with CRRT secondary to differences in ultrafiltration rates and dialysis membranes. The investigators propose an open label study to obtain peramivir pharmacokinetics in patients undergoing CRRT.

NCT ID: NCT01143532 Completed - Clinical trials for Kidney Transplantation

Role of Donor Genetics and Recipient Genetics in Kidney Transplant Outcomes

Start date: August 12, 2010
Phase:
Study type: Observational

Background: - Genetic variation in a particular chromosome is a major contributor to the increased risk for kidney disease that is common in people of African descent, although the specific gene, mutations, and other aspects of the variations remain to be determined. By studying the outcomes of kidney transplant in donors and recipients of African descent, researchers hope to better understand the effects of this genetic variation on the success of kidney transplants. Objectives: - To examine possible connections between genetic variations and kidney transplant outcomes for donors and recipients. Eligibility: - Participants in kidney transplant where both donor and recipient were of black African descent. - Eligible transplants include both living donor and deceased donor. Design: - The study will involve one visit of up to 8 hours. - All participants will provide a detailed personal and family medical history. - All participants will provide blood and urine samples, including a 24-hour urine collection, to test kidney function and collect material for genetic testing. - Donor participants will also have a magnetic resonance imaging (MRI) scan of their remaining kidney.

NCT ID: NCT01141179 Completed - Renal Impairment Clinical Trials

The Impact of Renal Impairment on the Pharmacokinetic and Pharmacodynamic of LEO 27847

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

The study will investigate the impact of reduced renal function on the pharmacokinetic and pharmacodynamic profile of LEO 27847. Volunteers with different degrees of renal impairment will be administered one dose of the investigational drug and then followed until investigational drug is eliminated from the body.

NCT ID: NCT01135979 Withdrawn - Renal Failure Clinical Trials

Assessment of the Sympathetic Nervous System Blockade of the Upper Limb After a Brachial Plexus Block in Patients With End Stage Renal Failure

Start date: February 2010
Phase: N/A
Study type: Observational

The purpose of this study is to investigate what effect a local anesthetic nerve block of the arm in patients with end stage renal failure has upon blood flow in the skin of the arm.

NCT ID: NCT01134900 Completed - Clinical trials for Kidney Failure, Acute

Achieving Medication Safety During Acute Kidney Injury

Start date: June 2010
Phase: N/A
Study type: Interventional

The utilization of clinical decision support (CDS) is increasing among healthcare facilities which have implemented computerized physician order entry or electronic medical records. Formal prospective evaluation of CDS implementations occurs rarely, and misuse or flaws in system design are often unrecognized. Retrospective review can identify failures but is too late to make critical corrections or initiate redesign efforts. A real-time surveillance dashboard for high-alert medications integrates externalized CDS interactions with relevant medication ordering, administration, and therapeutic monitoring data. The surveillance view of the dashboard displays all currently admitted, eligible patients and provides brief demographics with triggering order, laboratory, and CDS failure data to allow prioritization of high-risk scenarios. The patient detail view displays a detailed timeline of orders, order administrations, laboratory values, and CDS interactions for an individual patient and allows users to understand provider actions and patient condition changes occurring in conjunction with CDS failures. Clinical pharmacists' use of the dashboard for patient monitoring and intervention aims to increase the rate and timeliness of intercepted medication errors compared to CPOE-based CDS in the setting of acute kidney injury, which affects patients at various points across all hospital units and services and has numerous opportunities for intervention.

NCT ID: NCT01133795 Completed - Cirrhosis Clinical Trials

Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment

MAFRI
Start date: February 2010
Phase: Phase 2
Study type: Interventional

The objective of the study was evaluate the effect of administration of midodrine and albumin on renal function in patients with cirrhosis and creatinine greater than 1,2mg/dl.

NCT ID: NCT01131845 Completed - Clinical trials for Pulmonary Arterial Hypertension

The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil

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

This is a single-center, open-label, single-dose evaluation of 1 mg UT-15C SR pharmacokinetics, safety, and tolerability in subjects with normal, mild, moderate and end stage renal disease (ESRD; on dialysis). Subjects in the ESRD group will receive 2 doses of UT-15C SR, separated by 14 days. One dose will be given 4 hours prior to dialysis, the other dose will be given at the end of dialysis. Pharmacokinetic samples will be taken immediately prior to dosing and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 30, 36, 42 and 48 hours post dose. Additionally, subjects with ESRD will have a sample taken at 60 hrs post dose.

NCT ID: NCT01131091 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403

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

This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each.)