Clinical trials: Renal Transplant Recipient
Kidney Transplantation, Adverse Effects
Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids
The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney transplantation is associated with renal dysfunction and hypertension.
- Trial name
- NCT00284947
- Testing
- basiliximab, MMF/EC-MPS, Corticosteroids
- Where
- Switzerland
- Volunteers
- 7 people
- Sponsor
- Novartis
Kidney Transplantation
A Dose Escalation Study 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
- NCT04311632
- Testing
- TCD601, Tacrolimus (TAC), Corticosteroids (CS)
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- ITB-Med LLC
Kidney Transplant
The Adherence of Immunosuppressive Therapy Including Tacrolimus Once-daily in Italian Kidney Transplant Recipients
Non-adherence is widespread in the transplant community. Addressing issues associated with non-adherence remains a key challenge in transplantation, in part due to the difficulty in assessing its prevalence, as there is currently…
- Trial name
- NCT03558373
- Testing
- Immunosuppressive
- Where
- 12 sites in Italy
- Volunteers
- 158 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Kidney Transplant Recipients
An Open Label Study to Evaluate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Maintenance Renal Transplant Recipients
To evaluate whether maintenance renal transplant patients on micophenolate mofetil (MMF) can be safely converted to EC-MPS, based on adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen.
- Trial name
- NCT00239044
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplanted Recipients
SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus
The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure cyclosporine micro emulsion and…
- Trial name
- NCT00371826
- Testing
- Everolimus (RAD001), Cyclosporine (Calcineurin Inhibitor (CNI)), Methylprednisone/prednisone
- Where
- 7 sites in Australia
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
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
Renal Transplantation
Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.
- Trial name
- NCT01064791
- Testing
- sotrastaurin (Dose 1) + tacrolimus + standard of care medications, sotrastaurin (Dose 2) + tacrolimus + standard of care medications, sotrastaurin (Dose 3) + tacrolimus + standard of care medications
- Where
- 44 sites in United States, Argentina and 13 more
- Volunteers
- 298 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Failure, Graft vs Host Disease
Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus
Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune…
- Trial name
- NCT00195468
- Testing
- CYCLOSPORINE
- Where
- 13 sites in Brazil, Mexico
- Volunteers
- 280 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Renal Transplantation
Pharmacodynamics, Efficacy and Safety of Basiliximab 40 or 80 mg in Combination With Ciclosporine Microemulsion or Everolimus, in Adult Low Risk de Novo Renal Transplant Recipients (IDEALE Study)
The aims of this study are to extensively study the levels of CD25-Receptors saturation and expression obtained with 2 different doses of Simulect® in combination with Neoral® (i.e to demonstrate that saturation and expression…
- Trial name
- IDEALE (NCT01596062)
- Testing
- Simulect®, Neoral®, Certican®
- Where
- 3 sites in France
- Volunteers
- 16 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplantation
Safety, Tolerability and Efficacy of Everolimus With Lower Versus Higher Levels of Tacrolimus in de Novo Renal Transplant Patients
This study will assess the safety and efficacy of everolimus with basiliximab, corticosteroids and lower levels versus higher levels of tacrolimus in de novo renal transplant recipients.
- Trial name
- NCT00170833
- Testing
- Everolimus
- Volunteers
- 80 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplant Rejection
CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
This is a prospective, multi-site, observational study with a matched control group. The primary objective is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM…
- Trial name
- CLARITY (NCT05482100)
- Testing
- Patients monitored with OmniGraf testing
- Volunteers
- 500 people
- Sponsor
- Transplant Genomics, Inc.
Kidney Transplant, Immunosuppression
KidneyCare Immuno-optimization in Renal Allografts (KIRA)
This is an unblinded, randomized, four-arm interventional research study enrolling patients who are undergoing kidney transplantation.
- Conditions
- Kidney Transplant, Immunosuppression, Allograft
- Trial name
- NCT05423496
- Testing
- KidneyCare, steroid, MMF
- Sponsor
- CareDx
Chronic Hepatitis C Infection
A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients
The purpose of this study is to evaluate the safety and efficacy of ABT-450/r/ABT-267 with or without ABT-333 and with or without ribavirin (RBV) in adult liver or renal transplant recipients with hepatitis C virus (HCV) genotype…
- Trial name
- CORAL-I (NCT01782495)
- Testing
- ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir, ribavirin
- Volunteers
- 129 people
- Sponsor
- AbbVie
Kidney Transplantation
A Study to Evaluate the Effect of ASP8597 in Adult Kidney Transplant Patients
The purpose of this study is to evaluate the efficacy, safety and tolerability of a single intravenous dose of ASP8597 in kidney transplant recipients.
- Trial name
- NCT01442337
- Testing
- ASP8597
- Where
- 19 sites in United States
- Volunteers
- 21 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
An Open Study Assessing Bioavailability of a Modified Formulation of Tacrolimus in Kidney Transplant Recipients
The purpose of this study is to evaluate the effect of food on the oral bioavailability of tacrolimus modified release (MR4) capsules together with a standard continental breakfast.
- Trial name
- NCT00865137
- Testing
- Tacrolimus, modified release
- Where
- Netherlands
- Volunteers
- 27 people
- Sponsor
- Astellas Pharma Inc
Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients
Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients With Abnormal Glucose Metabolism From Tacrolimus to Cyclosporine Micro-emulsion
New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM.
- Trial name
- NCT00150085
- Testing
- cyclosporine micro-emulsion
- Volunteers
- 50 people
- Sponsor
- Novartis
Renal Transplantation
A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms
To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms
- Trial name
- NCT00658333
- Testing
- Enteric-coated Mycophenolate Acid (EC-MPA), Mycophenolate Mofetil (MMF)
- Where
- 37 sites in United States
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
- Trial name
- CIRRUS I (NCT03663335)
- Testing
- CFZ533 - Cohort 1/Cohort 2, Mycophenolate Mofetil (MMF), Corticosteroids (CS)
- Where
- 74 sites in United States, Argentina and 18 more
- Volunteers
- 418 people
- Sponsor
- Novartis Pharmaceuticals
Respiratory Syncytial Virus Infections
A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above
The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a…
- Trial name
- RSV OA=ADJ-023 (NCT05921903)
- Testing
- RSVPreF3 OA Investigational Vaccine
- Where
- 46 sites in United States, Australia and 6 more
- Volunteers
- 386 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Antibody-mediated Rejection
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)
In this study, researchers will learn more about the use of felzartamab in kidney transplant patients who have antibody-mediated rejection, also known as AMR. Kidney transplants can save lives for people with kidney failure.
- Trial name
- TRANSCEND (NCT06685757)
- Testing
- Felzartamab
- Where
- 56 sites in United States, Argentina and 10 more
- Volunteers
- 132 people
- Sponsor
- Biogen