Clinical trials: Transplantation, Kidney
Kidney Transplantation
Study To Evaluate the Status of Subjects That Discontinued Participation in a Qualifying Amgen Sponsored AMG 073 Study Due to Kidney Transplantation
The purpose of this study is to collect local laboratory data on immunoreactive parathyroid hormone (iPTH), calcium and phosphorus levels and estimated glomerular filtration rate (GFR) at approximately 1 week, 1 month, 3 months…
- Trial name
- NCT00110656
- Testing
- Observations
- Volunteers
- 38 people
- Sponsor
- Amgen
Renal Failure
Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients
A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf…
- Trial name
- NCT00496483
- Testing
- LCP Tacro (tacrolimus), Prograf
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Veloxis Pharmaceuticals
Kidney Transplant
Observational Registry Study of Renal Transplant Patients
The MORE Observational Study follows real-world renal transplant patients with the data resolution of a monitored, prospective clinical trial for 5 years.
- Trial name
- MORE registry (NCT01284257)
- Where
- 8 sites in United States
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplant Recipients
A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule
KTx recipients receiving cyclosporine-based immunosuppressive therapy, and in the opinion of the investigator would benefit from switch to a tacrolimus-based immunosuppression, will switch the immunosuppressive therapy to a…
- Trial name
- NCT02268201
- Testing
- Advagraf, Prograf
- Where
- 7 sites in China
- Volunteers
- 17 people
- Sponsor
- Astellas Pharma China, Inc.
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.
Renal Failure
Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily
This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3 controlled trial to establish the efficacy and safety of conversion from maintenance immunosuppressive therapy with Prograf® capsules…
- Trial name
- NCT00817206
- Testing
- LCP-Tacro, Prograf
- Where
- United States
- Volunteers
- 326 people
- Sponsor
- Veloxis Pharmaceuticals
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.
End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD)
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy
- Trial name
- TRANSFORM (NCT01950819)
- Testing
- Induction therapy, Corticosteroids, EVR+rCNI
- Where
- 184 sites in United States, Argentina and 40 more
- Volunteers
- 2,037 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation
The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in…
- Trial name
- NCT00189839
- Testing
- tacrolimus
- Where
- 80 sites in Argentina, Australia and 21 more
- Volunteers
- 699 people
- Sponsor
- Astellas Pharma Inc
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
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics 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.
De Novo Kidney Transplantation
Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients
The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405FR01) to continue on the same treatment and to assess the long-term safety of EC-MPS
- Trial name
- NCT00239018
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Volunteers
- 144 people
- Sponsor
- Novartis
Renal Transplantation
A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients
A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept
- Trial name
- NCT00650468
- Testing
- tacrolimus, CellCept, steroids (methylprednisone or prednisone)
- Where
- 29 sites in United States
- Volunteers
- 397 people
- Sponsor
- Astellas Pharma Inc
Organ Transplantation, Renal Transplantation
Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.
- Trial name
- CERTES02 (NCT00154284)
- Testing
- Everolimus (Certican), Cyclosporine (Neoral), Steroid
- Volunteers
- 114 people
- Sponsor
- Novartis
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, Kidney Diseases
Study Evaluating Sirolimus in the Treatment of Kidney Transplant
The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.
- Trial name
- NCT00282217
- Testing
- Sirolimus
- Where
- 13 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
Kidney Transplant Rejection
Transition of Renal Patients Using AlloSure Into Community Kidney Care
Patients undergoing kidney transplantation alone (either de-novo or re-transplant) at a participating hospital are routinely surveyed with interval blood tests as part of standard post-operative care through outpatient…
- Trial name
- TRACK (NCT04601155)
- Testing
- AlloSure
- Where
- 18 sites in United States
- Volunteers
- 248 people
- Sponsor
- CareDx
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