Clinical trials: Kidney Transplantation Recipients
Liver Transplantation
Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients
This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate…
- Trial name
- RAD (NCT00622869)
- Testing
- Tacrolimus (reduced tacrolimus), Tacrolimus (tacrolimus elimination), Tacrolimus (tacrolimus control)
- Where
- 91 sites in United States, Argentina and 17 more
- Volunteers
- 719 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation, Cytomegalovirus Infections
A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients.
- Trial name
- NCT01376804
- Testing
- valganciclovir [Valcyte]
- Where
- 25 sites in United States, Australia and 7 more
- Volunteers
- 57 people
- Sponsor
- Hoffmann-La Roche
Kidney Transplantation
Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients
This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.
- Trial name
- NCT00820911
- Testing
- cyclosporine (reduced exposure) / everolimus, AEB071 300 mg b.i.d. / everolimus, AEB071 200 mg b.i.d. / everolimus
- Where
- 28 sites in Argentina, Australia and 15 more
- Volunteers
- 175 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Allograft Nephropathy, Chronic Kidney Disease
Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck.
- Conditions
- Chronic Allograft Nephropathy, Chronic Kidney Disease, Chronic Renal Failure, Disordered Mineral Metabolism
- Trial name
- NCT00975000
- Testing
- Cinacalcet
- Where
- 51 sites in United States, Australia and 9 more
- Volunteers
- 114 people
- Sponsor
- Amgen
Kidney de Novo Transplant
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.
- Trial name
- NCT00238992
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Volunteers
- 144 people
- Sponsor
- Novartis Pharmaceuticals
CMV Disease
Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)
The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients.
- Trial name
- NCT03443869
- Testing
- Letermovir, Valganciclovir, Acyclovir (ACV)
- Where
- 94 sites in United States, Argentina and 14 more
- Volunteers
- 601 people
- Sponsor
- Merck Sharp & Dohme LLC
Renal Transplantation
Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)
The purpose of this observational study is to examine the clinical outcomes of the use of sirolimus as base therapy in kidney allograft recipients from Expanded Criteria Donors (ECD) under conditions of routine clinical practice.
- Trial name
- NCT00697112
- Testing
- Sirolimus
- Where
- 8 sites in Argentina
- Volunteers
- 53 people
- Sponsor
- Pfizer
Heart Transplantation, Kidney Transplantation
A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time
The purpose of this study is to compare how the body absorbs and processes two different formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children receiving an organ transplant, and how safe and…
- Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation
- Trial name
- NCT01614665
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 10 sites in Czechia, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Astellas Pharma Europe Ltd.
Liver Transplantation
Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy
The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as…
- Trial name
- NCT00378014
- Testing
- everolimus, basiliximab, CNI
- Where
- 16 sites in Austria, Germany and 2 more
- Volunteers
- 276 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
- Trial name
- NCT06365437
- Testing
- TCD601, Tacrolimus (TAC), Corticosteroids (CS)
- Where
- 7 sites in Austria, Spain and 1 more
- Volunteers
- 33 people
- Sponsor
- ITB-Med LLC
Renal Transplantation
Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.
Calcineurin inhibitors (CNI), a potent immunosuppressive drug used in kidney transplant recipients to prevent graft rejection, may cause renal impairment.
- Trial name
- NCT00332839
- Testing
- Everolimus, Cyclosporin A (CsA), Tacrolimus
- Where
- 11 sites in Germany
- Volunteers
- 93 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
The purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican) administered to pediatric renal transplant recipients, and to provide additional safety data.
- Trial name
- NCT00098241
- Testing
- Certican
- Where
- 2 sites in United States, Belgium
- Volunteers
- 45 people
- Sponsor
- Novartis Pharmaceuticals
End-stage Renal Disease
A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant
Primary Objective: To investigate the efficacy of the standard dose of Thymoglobuline® induction therapy for preventing acute rejection (AR) after transplantation among recipients of Donated after Cardiac Death (DCD) kidney…
- Trial name
- START-DCD (NCT03099122)
- Testing
- Rabbit Anti-thymocyte Immunoglobulin, Tacrolimus, Methylprednisolone
- Where
- China
- Volunteers
- 115 people
- Sponsor
- Sanofi
Transplant Rejection, Renal Transplantation
Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients
Sirolimus, 1 mg, white, triangular tablets (Rapamune®) was approved on 03 April 2007 in China for prophylaxis of organ rejection in renal transplantation.
- Trial name
- NCT01236378
- Testing
- Sirolimus
- Where
- 2 sites in China
- Volunteers
- 24 people
- Sponsor
- Pfizer
Stage V Chronic Kidney Disease
Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor
Primary Objective: To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.
- Trial name
- NCT01567085
- Testing
- Eculizumab
- Where
- 15 sites in Australia, France and 4 more
- Volunteers
- 80 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Antibody-mediated Rejection
Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients
This trial investigates the efficacy and safety of clazakizumab [an anti-interleukin (IL)-6 monoclonal antibody (mAb)] for the treatment of CABMR in recipients of a kidney transplant.
- Trial name
- IMAGINE (NCT03744910)
- Testing
- Clazakizumab, Physiologic saline solution
- Where
- 142 sites in United States, Australia and 13 more
- Volunteers
- 194 people
- Sponsor
- CSL Behring
Renal Transplantation
Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients
The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS.
- Trial name
- NCT00241059
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Volunteers
- 183 people
- Sponsor
- Novartis
Kidney Transplantation, Transplantation, Kidney
Belatacept and Risk of Post-transplant Lymphoproliferative Disorder in US Renal Transplant Recipients
To estimate the incidence rates of post-transplant lymphoproliferative disorder (PTLD) in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation To estimate the…
- Trial name
- NCT01656343
- Testing
- Calcineurin inhibitors (CNI), Belatacept
- Volunteers
- 775 people
- Sponsor
- Bristol-Myers Squibb
Renal Transplantation
This is a Two-year Follow-up Study to Evaluate the Long-term Safety, Tolerability and Efficacy of 2 Different Doses of Everolimus
This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.
- Trial name
- NCT00531063
- Testing
- Everolimus (RAD001)
- Where
- Switzerland
- Volunteers
- 237 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Envarsus® Once Daily With Everolimus in Elderly Kidney Transplant Recipients: Pharmacokinetic and Clinical Study
Prospective, single-arm, open-label, multicentre study with the principal aim to estimate tacrolimus pharmacokinetic parameters in elderly de-novo kidney transplant recipients of ECD (Extended Criteria Donor) kidney grafts…
- Trial name
- NCT02970630
- Testing
- Tacrolimus, Everolimus
- Where
- 6 sites in Italy
- Volunteers
- 28 people
- Sponsor
- Chiesi Farmaceutici S.p.A.