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Renal Transplantation clinical trials

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NCT ID: NCT02587052 Completed - Clinical trials for Renal Transplantation

A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis, GenTac

GenTac
Start date: October 2015
Phase:
Study type: Observational

This is a retrospective analysis of two different cohorts of patients that has undergone renal transplantation. This is a matched pair analysis of 100 patients treated with generic tacrolimus that will be compared with 100 matched controls treated with Prograf. Data will be obtained from patients' charts, from the Swedish National Kidney Registry and from a local registry at Transplantationscentrum. Patients included in the study are patients receiving a first single kidney transplant from a deceased or a living donor, treated with Prograf or Tacni and transplanted between transplanted January 2012 and August 2014. The 1-year-outcome of patients following renal transplantation, including BPAR, serious adverse effects and graft survival will be analysed.

NCT ID: NCT02564497 Completed - Clinical trials for Renal Transplantation

A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C

Start date: October 2, 2015
Phase: Phase 1
Study type: Interventional

The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects

NCT ID: NCT02238418 Completed - Clinical trials for Chronic Kidney Disease

Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria.

VITATOL
Start date: September 2014
Phase: Phase 4
Study type: Interventional

Vitamin D is not seen anymore only as a phosphocalcic and bone hormone, but also as having an effect on global health (anti-infective, anti-inflammatory, anti-tumour roles and cardiovascular protection). Until recently, vitamin D repletion was defined as the minimal concentration that enables the prevention of rickets in children and osteomalacia in adults, i.e, approximately 8 ng/mL (20 nmol/L). However, most of the international experts agree to set minimal threshold of 25 OH vitamin D serum concentration, higher than the one previously admitted, with a limit of 20 ng/mL (50 nmol/L) to define a vitamin D deficiency and a limit of 30 ng/mL (75 nmol/L) to define vitamin D insufficiency. Recommendations for Vit D supplementation in healthy children were updated in France in 2012. The invariable supplementation of infants and toddlers is efficient since deficiency-related rickets have almost disappeared; however there is very few information in ill children populations. Vit D supplementation tolerance is usually considered as good and over-dosage risks are low, however these studies were conducted more than 30 years ago, and as far as we know, there is no study about calcium urinary excretion kinetics after intake of a 100 000 IU vial of cholecalciferol (Uvedose®). When 25 OH vitamin D serum concentrations exceeds 200 ng/mL, which is very rare in daily practice, toxic effects of Vit D may theoretically be observed, particularly hypercalcemia and hypercalciuria. Vitamin D deficit is very common in children with chronic kidney disease (CKD) with a 50 to 92% prevalence depending on the studies; it it is a risk factor for secondary hyperparathyroidism. Although international guidelines regarding the care of CKD children recommend 25 OH vitamin D serum concentrations over 75 nmol/L, there are no practical recommendations in terms of dose and frequency of native Vit D treatment. Therefore, the objectives of the present study has are the following: - to validate prospectively the efficacy of our service usual care for Vit D supplementation of children and adolescents seen in the paediatric nephrology department. - and to study the effect of Vit D supplementation (100 000 IU vial of cholecalciferol) on calciuria in these patients.

NCT ID: NCT02147938 Completed - Clinical trials for Renal Transplantation

A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)

OPALE
Start date: July 17, 2014
Phase:
Study type: Observational

Assessment in a real situation of the conversion conditions, the efficacy and the safety of the treatment with tacrolimus in renal transplant patients converted from the tacrolimus twice per day form (Prograf®) to the tacrolimus once per day form (Advagraf®) with follow-up at one year. Analysis of two groups of patients: patients converted from Prograf® to Advagraf® early (during the first 6 months post-transplantation) or late (between 6 and 12 months post-transplantation).

NCT ID: NCT02020642 Completed - Clinical trials for Obstructive Sleep Apnea

Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx)

SASinTx
Start date: October 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect of renal transplantation on fluid overload and its consequence on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease. It aims further to investigate the relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.

NCT ID: NCT02010320 Completed - Clinical trials for Renal Transplantation

Computer Guided Doing of Tacrolimus in Renal Transplantation

OPTIMAL
Start date: January 2014
Phase: Phase 4
Study type: Interventional

Dosing of tacrolimus is challenging due to the large inter-individual variation in its pharmacokinetics. The investigators have developed a pharmacokinetics population model that can be used to estimate individual doses of tacrolimus in renal transplant recipients. The model will be prospective tested in a randomized clinical trial. The hypothesis is that the computer model is superior to experienced transplant physicians in reaching and keeping the patients in the target range of tacrolimus.

NCT ID: NCT01950819 Completed - Hemodialysis Clinical Trials

Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)

TRANSFORM
Start date: December 3, 2013
Phase: Phase 4
Study type: Interventional

This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.

NCT ID: NCT01899456 Completed - Hypertension Clinical Trials

Impact of Sympathetic Renal Denervation- a Study in Patients After Renal Transplantation

ISAR-denerve
Start date: July 2013
Phase: N/A
Study type: Interventional

The study is aiming to document the safety and effectiveness of renal denervation in patients after renal transplantation with hypertension. Catheter-based renal denervation will be performed using CE marked, percutaneous Symplicity catheter.

NCT ID: NCT01822483 Completed - Clinical trials for Renal Transplantation

A Prospective Study to Investigate Mycophenolic Acid (MPA) Exposure Through Area Under the Curve (AUC) in Renal Transplants Recipients Treated With Mycophenolate Mofetil (MMF) and After Conversion to Mycophenolate Sodium (EC-MPS)

AUC-MPA
Start date: April 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is investigate mycophenolic acid exposure through area under the curve in renal transplants recipients treated with mycophenolate mofetil and after conversion to mycophenolate sodium.

NCT ID: NCT01817504 Completed - Clinical trials for Renal Transplantation

Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure

DESYRE
Start date: March 2013
Phase: N/A
Study type: Interventional

Our hypothesis is early and systematic transplantectomy under a well-conducted immunosuppression is associated with a decreased risk of anti-HLA immunization against a conservative attitude including a gradual reduction of immunosuppression, with or without a transplantectomy performed for cause (clinical event). Observation or Investigation Method Used : The study is : - multicenter - prospective - open - randomized: patients are divided into two parallel groups: - study group: transplantectomy within six weeks after return to dialysis, antiproliferatives stop at the start of dialysis, Maintenance anticalcineurin-based-immunosuppression without dose reduction up to two weeks after transplantectomy. Abrupt discontinuation of anticalcineurin two weeks after transplantectomy. Corticosteroids: 5mg per day until one month after transplantectomy then stop within one month. - control group: No systematic transplantectomy. Antiproliferatives stop at the start of dialysis.Anticalcineurins half dose for 3 months, ¼ dose for 3 months and then stop. Corticosteroids:5 mg per day for 6 months, and then tapered and stop within 3 months. In the case of transplantectomy for cause in the control group, immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later,similary to systematic transplantectomy.