Clinical trials: Kidney Transplantation Recipients
Herpes Zoster
A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant
The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of 2 doses of PED-HZ/su, GSK's vaccine candidate for the prevention of Herpes Zoster (HZ) in immunocompromised paediatric renal transplant…
- Trial name
- NCT04006808
- Testing
- PED-HZ/su
- Where
- 31 sites in Belgium, France and 4 more
- Volunteers
- 184 people
- Sponsor
- GlaxoSmithKline
Kidney Transplantation
A Study to Evaluate the Safety and Efficacy of Prograf/FK778 and Prograf/MMF in de Novo Kidney Transplant Recipients
A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients
- Trial name
- NCT00282230
- Testing
- FK778
- Where
- 23 sites in United States
- Volunteers
- 150 people
- Sponsor
- Astellas Pharma Inc
Liver Transplantation
RESCUE Study - Everolimus in Liver Transplantation Recipients With Renal Insufficiency
The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related…
- Trial name
- NCT00267189
- Testing
- Everolimus, Calcineurin inhibitors (CNI), Mycophenolate acid (MPA)/ Azathioprine (AZA)
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 145 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
Kidney Transplantation, Primary Focal Segmental Glomerulosclerosis (FSGS)
Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients
The purpose of this study was to assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC) regimen (basiliximab induction, tacrolimus…
- Trial name
- NCT02921789
- Testing
- Bleselumab, Basiliximab, Mycophenolate Mofetil (MMF)
- Where
- 23 sites in United States, Canada
- Volunteers
- 67 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Antibody Mediated Rejection
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization…
- Trial name
- NCT01399593
- Testing
- Eculizumab
- Where
- 41 sites in United States, Australia and 8 more
- Volunteers
- 102 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Graft Rejection, Kidney Transplant
Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients
This study will look at the effect on long-term kidney function using tacrolimus right after a transplant and then switching to sirolimus at 3 to 5 months after the transplant.
- Conditions
- Graft Rejection, Kidney Transplant, Renal Allograft Recipients, Renal Transplant
- Trial name
- NCT00895583
- Testing
- Tacrolimus, Sirolimus
- Where
- 44 sites in United States, Argentina and 5 more
- Volunteers
- 254 people
- Sponsor
- Pfizer
Kidney Transplantation, Heart Transplantation
A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation
The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics).
- Conditions
- Kidney Transplantation, Heart Transplantation, Liver Transplantation
- Trial name
- OPTION (NCT01371331)
- Testing
- Tacrolimus granules
- Where
- 10 sites in Belgium, France and 4 more
- Volunteers
- 52 people
- Sponsor
- Astellas Pharma Europe Ltd.
KIDNEY TRANSPLANTATION
Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys
The purpose of this study is to explore the safety and efficacy of two different immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil [MMF] plus steroids versus tacrolimus plus MMF, following induction with…
- Trial name
- TIGRE (NCT00321113)
- Testing
- tacrolimus, mycophenolate mofetil, steroids
- Where
- 14 sites in Italy
- Volunteers
- 142 people
- Sponsor
- Astellas Pharma Inc
Liver Transplant, Kidney Transplant
A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients.
- Trial name
- ADDRESS (NCT02057484)
- Testing
- Tacrolimus
- Where
- 145 sites in Austria, Belarus and 22 more
- Volunteers
- 2,300 people
- Sponsor
- Astellas Pharma Europe Ltd.
Kidney Failure
Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
An open-label study to assess the safety, efficacy, and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor.
- Trial name
- NCT00497926
- Testing
- Enriched Hematopoietic Stem Cell Infusion
- Where
- 2 sites in United States
- Volunteers
- 37 people
- Sponsor
- Talaris Therapeutics Inc.
Chronic Hepatitis C, HCV
A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)
The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of ABT-493/ABT-530 (glecaprevir/pibrentasvir) in adults who are post primary orthotopic liver or renal transplant with chronic hepatitis C…
- Conditions
- Chronic Hepatitis C, HCV, Hepatitis C Virus
- Trial name
- NCT02692703
- Testing
- glecaprevir/pibrentasvir
- Volunteers
- 100 people
- Sponsor
- AbbVie
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
Skin Neoplasms, Kidney Transplantation
Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
The purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer (NMSC) in kidney transplant recipients.
- Trial name
- NCT00129961
- Testing
- sirolimus, cyclosporine or tacrolimus
- Where
- 23 sites in United States, Australia and 2 more
- Volunteers
- 86 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
End Stage Renal Disease
The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.
It is intended to examine the safety and efficacy of desensitization therapy by GB-0998 (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of pre-transplant desensitization.
- Trial name
- NCT02032095
- Testing
- GB-0998
- Where
- Japan
- Volunteers
- 17 people
- Sponsor
- Japan Blood Products Organization
de Novo Kidney Transplant Recipients, Renal Transplantation
Once-a-day Regimen With Everolimus, Low Dose Cyclosporine and Steroids in Comparison With Steroid Withdrawal or Twice a Day Regimen With Everolimus, Low Dose Cyclosporine and Steroids.
This study will compare the following immunosuppressive regimens in recipients of kidney transplantation: A) everolimus, cyclosporine and steroids given once-a-day; B) everolimus and cyclosporine given twice a day with steroid…
- Trial name
- EVIDENCE (NCT01023815)
- Testing
- everolimus, cyclosporine, Prednison (continuous steroids)
- Where
- 28 sites in Italy
- Volunteers
- 330 people
- Sponsor
- Novartis
Renal Transplantation
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.
- Trial name
- NCT00239902
- Testing
- FTY720
- Volunteers
- 396 people
- Sponsor
- Novartis Pharmaceuticals
Renal Failure
Induction of Donor Specific Tolerance in Recipients of Live Donor Kidney Allografts by Donor Stem Cell Infusion
The goal of this research study is to establish chimerism and avoid graft-versus-host disease in patients with kidney failure allowing a reduction or cessation of immune-suppressive therapy.
- Trial name
- NCT00498160
- Testing
- Enriched Hematopoietic Stem Cell Infusion
- Where
- 2 sites in United States
- Volunteers
- 38 people
- Sponsor
- Talaris Therapeutics Inc.
Renal Interstitial Fibrosis
Progression of Renal Interstitial Fibrosis / Tubular Atrophy (IF/TA) According to Epithelial-mesenchymal Transition (EMT) and Immunosuppressive Regimen (Everolimus Based Versus CNI Based) in de Novo Renal Transplant Recipients
Recently, early biomarkers of renal interstitial fibrosis have been identified, amongst them de novo expression of vimentin by tubular epithelial cells, which is an intermediate filament, and the translocation of beta-catenin…
- Trial name
- CERTITEM (NCT01079143)
- Testing
- Certican®, Neoral, Myfortic
- Where
- 23 sites in France
- Volunteers
- 194 people
- Sponsor
- Novartis Pharmaceuticals