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Transplant;Failure,Kidney clinical trials

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NCT ID: NCT03380962 Active, not recruiting - Clinical trials for Kidney Failure, Chronic

Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant

Start date: February 27, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Patients who have had a previous allograft failure represent a major problem for transplant centers as they are highly-human leukocyte antigen (HLA) sensitized and unlikely to receive another transplant without significant desensitization. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling twenty patients (ages 15-75) who will begin desensitization therapy to achieve HLA incompatible (HLAi) renal transplantation. Patients who qualify will receive up to 6 doses of clazakizumab 25 mg monthly pre-transplantation. If patients receive an HLAi transplant during the study, the participants will continue to receive another 6 monthly doses of clazakizumab 25 mg, followed by a 6 month protocol biopsy. Patients will continue another 6 doses over 6 months if improvements are seen after the 6th dose of clazakizumab. Patients who develop evidence of persistent allograft dysfunction may have non-protocol biopsies for cause. Patients who receive 12 doses of clazakizumab post-transplant will receive a 12M protocol biopsy.

NCT ID: NCT03322709 Not yet recruiting - Clinical trials for Transplant;Failure,Kidney

Minimally Invasive Kidney Transplantation

Start date: December 2017
Phase: N/A
Study type: Observational

This study aims to investigate the effect of robot-assisted laparoscopic kidney transplantation on kidney injury by measuring biomarkers of kidney injury which are found in blood and urine to establish if there is a significant difference between robotic and open surgery. The study will also investigate the potential benefits of minimally invasive surgery on the surgical trauma associated with open surgery by assessing the surgical stress response between groups of kidney transplant patients receiving either open or minimally invasive kidney transplants and by comparing wound healing with patients undergoing donor nephrectomy.

NCT ID: NCT03310905 Recruiting - Clinical trials for Transplant;Failure,Kidney

Abdominal Wall Transplant

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation may be performed alone or in combination with another transplant.

NCT ID: NCT02559297 Completed - Clinical trials for Transplant; Failure, Kidney

Effects of Sevoflurane and Desflurane on Treg

Start date: August 10, 2015
Phase: Phase 2
Study type: Interventional

This prospective interventional study aims to compare sevoflurane and desflurane anesthetic agents on regulatory T cell (Treg) numbers and its cytokine production in patients undergoing Living Donor Kidney Transplant (LDKT).

NCT ID: NCT02213068 Completed - EBV Clinical Trials

Belatacept 3 Month Post Transplant Conversion Study

Start date: July 2014
Phase: Phase 4
Study type: Interventional

This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months after kidney transplantation. The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking the transplanted organ. The primary purpose of this research study is to evaluate the effects of three (3) different immunosuppressive treatments on rejection in post-transplant kidney recipients. This study will test whether switching from tacrolimus to belatacept will improve long-term kidney function. Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug Administration (FDA) to be used after transplant. All of these medications have been routinely used in kidney recipients here at Northwestern University. Belatacept (the "study drug") has been approved by the FDA for use at the time of transplant. However, the use of belatacept in this study is considered investigational as it has not been FDA approved for use beginning at 3 months after transplant. This study will involve 51 adult kidney transplant recipients at Northwestern.

NCT ID: NCT01913392 Completed - Obesity, Morbid Clinical Trials

Effect of Laparoscopic Sleeve Gastrectomy in the Morbidly Obese, Kidney Transplant Candidate

Start date: July 18, 2013
Phase:
Study type: Observational

A prospective clinical trial will study the effects of laparoscopic sleeve gastrectomy in the potential renal transplant candidate who is denied acceptance due mainly to the morbid obesity.

NCT ID: NCT01883583 Recruiting - Clinical trials for Transplant; Failure, Kidney

Pilot Study of Contrast-Enhanced Ultrasound of Transplanted Kidney

Start date: June 2013
Phase: N/A
Study type: Interventional

To check the possibility of the acquisition of a number of parameters through real-time contrast-enhanced ultrasound and sonoelastography images and to verify the correlation with pathologic results from ultrasound guided biopsy of transplanted kidney

NCT ID: NCT01709097 Completed - Clinical trials for Medication Adherence

Compliance/Adherence After Kidney Transplant, With or With Out Med-O-Wheel™.

C/A
Start date: June 2011
Phase: N/A
Study type: Observational

Background: Adherence to the immunosuppressive drug regimen is critical to the outcome after an organ transplant. Patients need to take their prescribed medications and attend their appointments with the doctor. Based on previous studies in other European countries, the cost of non-compliance after organ transplantation in Sweden is >SEK 35 million/year. Patients who lose their graft both lose quality of life and have decreased expected survival; moreover, retransplantation may be hampered by new HLA antibodies. Question: The primary question is whether Med-O-Wheel™ can improve compliance to the prescribed medication regimen in renal transplant patients. Methods and materials: All kidney transplant patients at Karolinska University Hospital, Huddinge, will be given information about the study and will then be asked to participate. Participants will be randomized into two arms, one arm with and one with out Med-O-Wheel™. The 80 included patients will be closely monitored for 1 year regarding intake of prescribed medications. Med-O-Wheel™ is an electronic medication dispenser that records the date and time of each occasion when the patient takes medications from the dispenser. It has a SIM card and text messaging capabilities. Addoz Portal™ is a web-based application that makes it possible to monitor and analyse medication intake. Each event in the medication dispenser is registered in the portal, which communicates with the care provider/support person by text message, e-mail or telephone. Significance of the study: In the future it may be possible to improve compliance in transplant patients. In particular, patients will feel secure since they will receive confirmation through the portal that they are taking their medications safely and accurately.

NCT ID: NCT01680861 Completed - Clinical trials for Transplant; Failure, Kidney

Tacrolimus/Everolimus Versus Tacrolimus/Enteric-Coated Mycophenolate Sodium

Start date: November 2012
Phase: Phase 3
Study type: Interventional

A recent therapeutic strategy following renal transplantation includes simultaneous use of reduced calcineurin inhibitor (CNI) dosing and maximized use of a non-nephrotoxic, antiproliferative drug (inosine monophosphate dehydrogenase (IMPDH) or TOR inhibitor), with the goals of reducing/avoiding CNI nephrotoxicity, the incidence of acute rejection, and chronic allograft injury (CAI) (i.e., interstitial fibrosis/tubular atrophy), leading to more favorable longer-term patient and graft survival.1-7 Early corticosteroid withdrawal has also been used in the attempt to avoid well-known side effects while maintaining favorable patient and graft survival.8-10 While the investigators center and numerous other centers have also included single agent, antibody induction utilizing the lymphodepleting polyclonal antibody rabbit anti-human thymocyte globulin (ATG), nondepleting human anti-interleukin-2 receptor (CD25) monoclonal antibody daclizumab (Dac) or basiliximab, or lymphodepleting humanized anti-CD52 monoclonal antibody alemtuzumab,11-17 evidence now suggests that an even more effective induction strategy may include the combined use of more than one induction agent (each with fewer doses than if used alone), with the goal of bringing the kidney transplant recipient even closer (through more effectively timed lymphodepletion) to an optimally immunosuppressed state, allowing further reduction in long-term maintenance drug dosing.18-25 The investigators have now successfully used dual ATG/Dac induction therapy in both kidney-alone23-24 and simultaneous kidney-pancreas (SPK) transplantation,18-20 and a recent report from the investigators center of kidney-alone and SPK recipients shows that the addition of anti-CD25 to ATG for induction therapy more effectively delays the return of peripheral blood CD25+ cells.25 In the kidney-alone recipient study 3 doses of ATG were combined with 2 doses of Dac for induction,23-24 vs. the investigators previous studies utilizing single agent induction with 7 doses of ATG or 5 doses of Dac.4,16,17 Successful combination of ATG/basiliximab as dual induction in kidney transplantation has also been reported elsewhere,21-22 along with equivalency in clinical outcomes using daclizumab vs. basiliximab.13

NCT ID: NCT01679184 Terminated - Clinical trials for Transplant; Failure, Kidney

XM-One Study for Living Donor Program

Start date: June 2013
Phase: N/A
Study type: Observational

Donor-Specific Antibody (DSA) (HLA) levels and non-HLA antibody levels in recipients prior to living kidney transplantation and randomize these individuals into a desensitization protocol in order to evaluate shifts that can occur with the Luminex and XM-One assay after treatment and up to 6 months post transplant. If desensitization is needed prior to transplantation in individuals with a negative crossmatch but positive DSA and/or XM-one - patients will be evaluated clinically with routine lab tests (serum creatinine levels, spot urine protein and spot urine creatinine levels) as well as protocol biopsy evaluations.