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Kidney Transplantation clinical trials

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NCT ID: NCT03848585 Terminated - Clinical trials for Kidney Transplant; Complications

Medicine Adherence and Effects on Transplants With Pilloxa's Electronic Pillbox

Start date: November 29, 2018
Phase: N/A
Study type: Interventional

Poor adherence to medication among patients with chronic diseases is a major problem. A patient group where the adherence to prescribed medications is extremely important are organ transplanted patients. It is well established that lack of adherence to immunosuppressive medication drastically increases the risk of rejection reactions, graft loss and deaths. Pilloxa is a device meant to help users manage medication and support adherence to medication. This study evaluates if Pilloxa improves adherence to treatment for transplanted patient compared with conventional management. Patients who have received a transplanted kidney or liver will be studied. Pilloxa is a system comprising of: a box with 14 separate containers to temporarily store tablets/capsules in and that can be open by 14 independent lids, a smartphone application and cloud based servers. The pillbox will at given times detect if pills are present in the different compartments and can connect, send and receive information to/from mobile application and the cloud.

NCT ID: NCT03841097 Recruiting - Clinical trials for Kidney Transplant; Complications

Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants

PTAAK
Start date: November 11, 2019
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to evaluate the pulse wave velocity and vascular compliance measurements at the beginning and the end of the study while the participants are taking either extended release tacrolimus tablets (known by brand name Envarsus XR®, and also referred to as LCPT in this study) given once-daily each morning after transplantation or immediate release tacrolimus capsules (also known by brand name Prograf® or abbreviation IR-TAC in this study) that are administered twice-daily 12 hours apart after kidney transplantation. Pulse wave velocity and vascular compliance measurements are two non-invasive tests that are used to evaluate how well the blood vessels adapt to each heartbeat. The secondary purpose is to look at the effectiveness and safety of LCPT given once-daily compared to IR-TAC given twice-daily 12 hours apart after kidney transplantation.

NCT ID: NCT03837522 Completed - Kidney Transplant Clinical Trials

Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies

Start date: September 17, 2019
Phase: N/A
Study type: Interventional

The purpose of this research study is to compare the impact of the availability of biopsy results at the time of organ offers on the use and outcomes of kidneys from deceased donors.

NCT ID: NCT03834142 Completed - Pain, Postoperative Clinical Trials

NSS-2-BRIDGE Study for Total Knee and Hip Arthroplasties, Bariatric, and Kidney Transplant Surgeries

Start date: March 8, 2019
Phase: N/A
Study type: Interventional

The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depression, immunosuppression, constipation, and most recently, addiction. In the United States, over $600 billion is spent every year on opioid addiction, including $79 billion related to opioid addiction following surgery. Despite many initiatives to decrease the use of opiates in the preoperative setting, opioids continue to be regularly prescribed before, during and after surgery. Although the risk of opioid addiction following surgery is recognized, the percentage of patients becoming addicted to opioids following surgery is not well understood. To date, there has been virtually no agreement regarding the duration and dosage that qualify for opioid dependence following surgery, nor that a clear estimation of the factors such as biological, psychosocial and socioeconomic that increase the risk of using opioids for extended periods of time after surgery. Therefore, in order to combat this growing health crisis at the ground level, it is incumbent upon the medical community to explore alternative methods of pain control to treat the surgical population in order to change the incidence of post-operative opioid addiction. Percutaneous Nerve Field Stimulation (PNFS) is one of these recognized methods that ongoing research has shown to be effective as a complementary method of pain management. While PNFS is not a novel concept, clinical indications of auricular field stimulation have been limited in the past due to requirement of bulky, stationary and non-disposable stimulators and electrodes. These technological limitations made it difficult to establish the real clinical potential of auricular stimulation for the perioperative management of pain in surgical patients, despite the demonstration that auriculotherapy has been shown to relieve pain in the postoperative setting. The NSS-2- BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. These symptoms include pain, anxiety and post-operative nausea and vomiting; conditions which are also present following major orthopedic surgery such as knee and hip arthroplasties. The use of the NSS-2 BRIDGE device has been demonstrated to provide significant analgesia in patients with abdominal pain syndrome, and clinical trials are ongoing to assess the benefit of this approach for post-operative pain management. As compared to the present use of opioids for perioperative pain management, the use of a complementary, non-pharmacologic approach offers the advantage of analgesia without the associated side effects.

NCT ID: NCT03829488 Completed - Clinical trials for Kidney Transplant; Complications

Better Evidence for Selecting Transplant Fluids

BEST-Fluids
Start date: January 26, 2018
Phase: Phase 3
Study type: Interventional

End-stage kidney disease (ESKD) is a significant, expensive health problem. Kidney transplantation improves survival, quality of life, and is much cheaper than dialysis treatment for ESKD. However sometimes kidney transplants from a deceased donor function poorly after surgery, and a period of continued dialysis is needed, a condition known as delayed graft function (DGF). In addition to complicating recovery, DGF can adversely affect long-term kidney function and the health of the recipient. Intravenous fluids given during and after transplantation (usually 0.9% sodium chloride or saline) are critical to preserve kidney transplant function, but there is evidence that 0.9% saline may not be the safest fluid to use due to its high chloride content. BEST Fluids is a randomised controlled trial that aims to find out whether using a balanced low-chloride solution - Plasma-Lyte 148® - as an alternative to normal saline in deceased donor kidney transplantation, will improve kidney transplant function, reduce the impact of DGF, and improve long-term outcomes for patients.

NCT ID: NCT03828682 Recruiting - Clinical trials for Kidney Transplantation

Veloxis de Novo Kidney Transplant ECSWD

Start date: June 21, 2019
Phase: Phase 4
Study type: Interventional

This study is designed to evaluate the safety and efficacy of LCPT in combination with rATG, mycophenolate and early corticosteroid withdrawal (CSWD) in de novo kidney transplant recipients.

NCT ID: NCT03819686 Completed - Kidney Transplant Clinical Trials

Reducing Disparities in Living Donor Transplant Among African Americans

Start date: February 4, 2019
Phase: N/A
Study type: Interventional

For most of the patients in the United States with end stage renal disease (ESRD), kidney transplantation represents the optimal treatment, and living donor kidney transplantation (LDKT) is preferable. Nevertheless, there are pervasive racial disparities in access to LDKT. The main outcome of this study is change in the proportion of study participants who have at least one living donor inquiry by friends/family over study period.The long-term objective is to understand the combined effect of a systems-level intervention (Transplant Referral EXchange or T-REX) and a culturally-sensitive individual-level educational intervention (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities in access to LDKT.

NCT ID: NCT03818698 Active, not recruiting - Clinical trials for Kidney Transplantation

Study of Eplets Matching in Kidney Transplantation

Start date: April 1, 2019
Phase:
Study type: Observational

The rapid changes of tissue-typing technology, including the widely used of highly specific molecular typing methods and solid phase analysis technology for detection of alleles specific anti-HLA antibodies, promoted the selection of organ transplant recipients to a more accurate level and promoted the scientific development of organ transplant matching. At present, the graft survival rate has been greatly improved through the prevention and treatment of T-cell-mediated rejection (TCMR), but the humoral immune response, the main cause of late graft loss, is still not effectively controlled. HLA eplets matching is based on the principle that if a donor HLA antigen shares a specific epitope with a recipient's HLA antigen, that eplets will not be recognized as foreign and will therefore not provoke a humoral immune response. The selection of transplant recipients based on this principle can avoid antibody-mediated rejection (AMR), reduce sensitization after transplantation, and select the most appropriate organs to avoid pre-existing antibodies in the case of persisting HLA antibody positive recipients choosing. In this study, the HLA high-resolution typing data of kidney transplant recipients from 2014 to the end of 2017 were analyzed with HLA Matchmaker for eplets mismatching number. To analyze the incidence of dnDSA and AMR after kidney transplant recipients with different eplets mismatching number posttransplant, and to elucidate the important role of tissue configuration patterns based on HLA eplets matching in long-term graft survival.

NCT ID: NCT03812419 Completed - Clinical trials for Kidney Transplant; Complications

Esomeprazole or Pantoprazole in Renal Transplantation

Start date: January 5, 2016
Phase: N/A
Study type: Interventional

prospective, parallel, open-label clinical trial was performed on forty-seven adult renal transplant recipients receiving immunosuppressive therapy with CsA doses adjusted to attain trough concentrations of 100-150 μg/L, mycophenolate mofetil (MMF) at 750 mg q12 hr and prednisolone at 5 mg daily randomized into two groups, which received esomeprazole or pantoprazole at the same dose (40 mg once daily). To compare the influence of pantoprazole and esomeprazole on serum cyclosporine (CsA) levels in stable renal transplant recipients.Cyclosporine (C0), renal function and complete blood count were measured at baseline and for 6 months. Main outcome measures Clinical signs of rejection and renal function decline, assessed by serum creatinine elevations, caused by CsA level variations in either of the study groups.

NCT ID: NCT03809533 Active, not recruiting - Hepatitis C Clinical Trials

The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients

Start date: May 29, 2019
Phase: Phase 2
Study type: Interventional

This is an open-label, pilot trial to test the safety and efficacy of transplantation of kidneys from hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the kidney transplant waitlist. Treatment and prophylaxis will be administered using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).