Clinical trials: Transplant Patients
Kidney Transplant
A Study Of CP-690,550 In Stable Kidney Transplant Patients
This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients.
- Trial name
- NCT01710033
- Testing
- CP-690,550 5 mg BID, CP-690,550 15 mg BID, CP-690,550 30 mg BID
- Where
- 11 sites in United States
- Volunteers
- 28 people
- Sponsor
- Pfizer
Immunosuppression in Solid Organ Transplant
Belatacept in Liver Transplant Recipients
The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant
- Trial name
- NCT00555321
- Testing
- Tacrolimus, Basiliximab, Belatacept More Intensive (MI)
- Where
- 42 sites in United States, Argentina and 7 more
- Volunteers
- 260 people
- Sponsor
- Bristol-Myers Squibb
Corneal Diseases, Cornea Transplant
Study to Assess the Efficacy and Safety of LX201 for Prevention of Corneal Allograft Rejection Episodes and Graft Failure in Subjects at Increased Immunological Risk
This was a pivotal trial to determine whether LX201 reduces the likelihood of a graft rejection episode following corneal transplantation in patients at high immunological risk for rejection.
- Trial name
- NCT00447187
- Testing
- LX201
- Where
- 30 sites in United States, Germany
- Volunteers
- 368 people
- Sponsor
- Lux Biosciences, Inc.
Lung Transplant
Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients
Currently there are no approved therapies for lung transplant recipients in the United States (US). Treatment with CIS following lung transplantation has previously been demonstrated to result in a clinically meaningful…
- Trial name
- NCT00633373
- Testing
- Cyclosporine Inhalation Solution
- Where
- 8 sites in United States
- Sponsor
- APT Pharmaceuticals, Inc.
Lung Transplant
Study of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation
A Phase III, multi-center, randomized, controlled study designed to demonstrate the efficacy and safety of Cyclosporine Inhalation Solution (CIS)in improving survival and preventing bronchiolitis obliterans syndrome (BOS) when…
- Trial name
- CIS001 (NCT00755781)
- Testing
- Cyclosporine Inhalation Solution (CIS)
- Where
- 19 sites in United States, Canada
- Volunteers
- 284 people
- Sponsor
- APT Pharmaceuticals, Inc.
Lung Transplant
CIS001 Extension Study of Cyclosporine Inhalation Solution
This trial is a longterm follow up of a phase III study of inhaled cyclosporine for the prevention of chronic rejection in lung transplant recipients.
- Trial name
- CIS002 (NCT00938236)
- Testing
- Cyclosporine Inhalation Solution (CIS)
- Where
- 16 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- APT Pharmaceuticals, Inc.
Renal Transplant
Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients
The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.
- Trial name
- NCT01256294
- Testing
- Generic Tacrolimus, Branded Tacrolimus
- Where
- 2 sites in United States
- Volunteers
- 71 people
- Sponsor
- Novartis
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
Liver Transplant, Hepatitis C
Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus
Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases and over time causes fibrosis and eventually cirrhosis of the new liver.
- Trial name
- NCT00260208
- Testing
- Cyclosporine A, Tacrolimus
- Where
- 2 sites in United States, Switzerland
- Volunteers
- 361 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplant
Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A0107
Aim of study is to provide safety and tolerability data on enteric-coated mycophenolate sodium in regard to adverse events, serious adverse events and patient and graft survival.
- Trial name
- NCT00149916
- Testing
- Mycophenolate sodium (enteric coated)
- Volunteers
- 139 people
- Sponsor
- Novartis Pharmaceuticals
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
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
De Novo Kidney Transplant
MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive
To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard…
- Trial name
- NCT00284921
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplant
Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients
The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy compared to tacrolimus monitored…
- Trial name
- NCT00149994
- Testing
- Cyclosporine A, Tacrolimus, Basiliximab
- Where
- Switzerland
- Volunteers
- 171 people
- Sponsor
- Novartis Pharmaceuticals
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 Transplant
Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302
Aim of study is to collect long term safety data on enteric-coated mycophenolate sodium 720 mg bid in combination with cyclosporine with/without steroids in regard to adverse events, serious adverse events, and patient and graft…
- Trial name
- NCT00149864
- Testing
- Mycophenolate sodium (enteric coated)
- Volunteers
- 264 people
- Sponsor
- Novartis
Renal Transplant
Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301
Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival.
- Trial name
- NCT00149929
- Testing
- Mycophenolate sodium (enteric coated)
- Volunteers
- 246 people
- Sponsor
- Novartis
Kidney Transplant
Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants
Evaluate the incidence of acute rejection at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Phase I) with subjects…
- Trial name
- NCT00257387
- Testing
- Cyclosporine
- Volunteers
- 120 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
De Novo Kidney Transplant Recipients
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
This trial is designed to assess the efficacy, tolerability, and safety of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in kidney transplant recipients.
- Trial name
- NCT00312143
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Volunteers
- 35 people
- Sponsor
- Novartis
Liver Transplant
Efficacy and Safety of Cyclosporine Microemulsion Given Once a Day in Adult Stable Liver Transplant Recipients
The purpose of this study is to determine whether cyclosporine microemulsion given once a day instead of twice a day benefits kidney function, blood pressure, lipid profile and glucose control in stable liver transplant…
- Trial name
- NCT00171509
- Testing
- Cyclosporine microemulsion
- Volunteers
- 61 people
- Sponsor
- Novartis