Clinical trials: Transplantation, Kidney
Renal Transplantation
Intensified vs. Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Microemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients
This study will assess the association of an initially intensified dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) during the first 6 weeks post renal transplantation with acute rejections relative to the rapid…
- Trial name
- NCT00369278
- Testing
- Enteric-coated mycophenolate sodium (EC-MPS)
- Where
- Germany
- Volunteers
- 128 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients
The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.
- Trial name
- NCT00154206
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation, Transplantation Immunology
A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Kidney Transplant Recipients
The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF in de novo kidney transplant recipients.
- Conditions
- Kidney Transplantation, Transplantation Immunology, Host vs Graft Reaction
- Trial name
- NCT00717678
- Testing
- Prograf-XL, Prograf, MMF
- Where
- 5 sites in Taiwan
- Volunteers
- 73 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplant
A Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients
This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with corticosteroid to Advagraf® with corticosteroid.
- Trial name
- COSMOS (NCT02034747)
- Testing
- Advagraf, Corticosteroid
- Where
- 9 sites in South Korea
- Volunteers
- 150 people
- Sponsor
- Astellas Pharma Korea, Inc.
Kidney Transplant Rejection
Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care
This is an observational study in renal transplant recipients to evaluate the acceptability, feasibility, and clinical utility of TruGraf® testing in conjunction with standard clinical assessment.
- Trial name
- NCT04267016
- Testing
- TruGraf Testing - Peripheral blood gene expression profiling
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Transplant Genomics, Inc.
Heart Transplantation, Kidney Transplantation
A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients
The purpose of this study, a follow up to study FG506-CL-0403, is to see how safe and effective Modigraf® is (Part A) and to see how safe and effective it is to change your child's medication from Modigraf® to Prograf® (Part B).
- Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation
- Trial name
- PROGRESSION (NCT01371344)
- Testing
- Tacrolimus granules, Tacrolimus capsules
- Where
- 12 sites in Belgium, France and 4 more
- Volunteers
- 47 people
- Sponsor
- Astellas Pharma Europe Ltd.
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
Renal Transplantation
Extension Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients
This extension study is to assess the long-term safety of EC-MPS
- Trial name
- NCT00239070
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Volunteers
- 69 people
- Sponsor
- Novartis
Focal Segmental Glomerulosclerosis
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
Liposorber® LA-15 System is a blood purification therapy that selectively removes malignant lipoproteins including low density lipoprotein from circulating blood flow and rapidly reduces the plasma cholesterol level.
- Trial name
- FSGS pediatric (NCT02235857)
- Testing
- LIPOSORBER® LA-15 System
- Where
- 12 sites in United States
- Volunteers
- 35 people
- Sponsor
- Kaneka Medical America LLC
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
Renal Transplant
Assessment of Effectiveness of Belatacept Patient Alert Card in Patients Following Renal Transplantation in a Sample of EU Countries
The purpose of the study is to determine a) if the implementation of belatacept patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is…
- Trial name
- NCT02581644
- Where
- 14 sites in Austria, France and 2 more
- Volunteers
- 63 people
- Sponsor
- Bristol-Myers Squibb
Kidney Transplantation, Kidney Failure, Chronic
Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population.
- Conditions
- Kidney Transplantation, Kidney Failure, Chronic, Renal Insufficiency, Chronic
- Trial name
- NCT00717379
- Testing
- Tacrolimus, Mycophenolate Mofetil, Methylprednisolone or equivalent
- Where
- 6 sites in Russia
- Volunteers
- 50 people
- Sponsor
- Astellas Pharma Inc
Renal Transplant
Measurement of Patient Reported Outcomes in Korean Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms
This study will evaluate the impact that GI complaints have on patient-reported outcomes and to determine if there is improvement in patient-reported outcomes when converted from mycophenolate mofetil (MMF) to Enteric-coated…
- Trial name
- NCT00529269
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Where
- 2 sites in South Korea
- Volunteers
- 200 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplant Rejection
Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of human leukocyte antigen (HLA)-matched, living…
- Trial name
- NCT03363945
- Testing
- MDR-101
- Where
- 19 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Medeor Therapeutics, Inc.
Kidney Transplant Rejection
Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection
Global, non-randomized, observational study for the validation of Verici Dx genomic tests to predict risk of kidney clinical and subclinical acute rejection, and chronic allograft damage or interstitial fibrosis / tubular atrophy…
- Trial name
- NCT04727788
- Where
- 13 sites in United States, France and 2 more
- Volunteers
- 550 people
- Sponsor
- Verici Dx
Kidney Transplantation, Liver Transplantation
Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From Gastrointestinal (GI) Adverse Events While on Mycophenolate Mofetil Therapy (MMF) Therapy
This open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted patients suffering from gastrointestinal adverse events while on…
- Trial name
- NCT00149942
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Where
- Switzerland
- Volunteers
- 23 people
- Sponsor
- Novartis
Kidney Transplantation
REgulatory T Cell Therapy to Achieve Immunosuppression REduction
The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor…
- Trial name
- RETIRE (NCT06552169)
- Testing
- Arm 1: SOC (mTOR + CNI), Arm 2A: TRACT/MONO mTOR, Arm 2B: TRACT/MONO CNI
- Where
- 7 sites in United States, Taiwan
- Volunteers
- 34 people
- Sponsor
- Singulera Therapeutics Inc.
Kidney Transplantation
Quality of Life Questionnaire Validation for Patients With Changed Tacrolimus Dosing After Kidney Transplantation
The purpose of this study is to develop and validate a questionnaire to assess the quality of life when the recipients of kidney transplantation switched their medication from tacrolimus twice daily (BID regimen) to Advagraf…
- Trial name
- NCT03623217
- Testing
- Qualitative interviews with participants
- Where
- South Korea
- Volunteers
- 56 people
- Sponsor
- Astellas Pharma Korea, Inc.
Cytomegalovirus Infections
A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls
This observational study will compare spermatogenesis in male adult renal transplant recipients receiving valganciclovir versus untreated matched controls.
- Trial name
- NCT01663740
- Testing
- Valganciclovir
- Where
- 19 sites in United States, Mexico
- Volunteers
- 59 people
- Sponsor
- Hoffmann-La Roche
Kidney Transplantation
CCFZ533X2201 - PoC Study in de Novo Renal Transplantation
The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar rate of acute rejection prophylaxis and…
- Trial name
- NCT02217410
- Testing
- CFZ533, Tacrolimus (Tac), Mycophenolate mofetil (MMF)
- Where
- 14 sites in United States, Brazil and 2 more
- Volunteers
- 59 people
- Sponsor
- Novartis Pharmaceuticals