Renal Transplantation Clinical Trial
Official title:
An Open-Label, Non-Randomized Study To Evaluate The Steady-State Pharmacokinetics Of Sirolimus Tablets In Chinese Patients With Stable Renal Allografts
Sirolimus, 1 mg, white, triangular tablets (Rapamune®) was approved on 03 April 2007 in
China for prophylaxis of organ rejection in renal transplantation. A pharmacokinetic (PK)
study to be conducted in renal allograft recipients was requested by State Food and Drug
Administration (SFDA) to provide further guidance for clinical use.
To minimize risk to patients, this study is designed to collect blood PK samples from renal
allograft recipients who are currently under sirolimus (1 mg tablets) treatment with or
without concomitant medication(s). PK samples will be collected from these patients to
characterize the steady state PK of sirolimus during sirolimus maintenance therapy. This
study will not involve any changes to the established treatment regimen for the patients who
enroll in the study
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06026592 -
Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
|
||
| Active, not recruiting |
NCT02444429 -
3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation
|
Phase 3 | |
| Completed |
NCT02238418 -
Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria.
|
Phase 4 | |
| Completed |
NCT01729494 -
Belatacept Early Steroid Withdrawal Trial
|
Phase 4 | |
| Terminated |
NCT01436305 -
Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation
|
Phase 2 | |
| Completed |
NCT02843295 -
Catalytic Antibodies to Predict Uninvasively Late Transplant Failure
|
N/A | |
| Terminated |
NCT01276834 -
Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation
|
Phase 4 | |
| Completed |
NCT00842699 -
Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab
|
N/A | |
| Completed |
NCT00525681 -
Interaction Between Rimonabant and Cyclosporine and Tacrolimus
|
Phase 4 | |
| Completed |
NCT00776750 -
Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients
|
Phase 4 | |
| Completed |
NCT00189735 -
A Study to Evaluate FK778 in Kidney Transplant Patients
|
Phase 2 | |
| Recruiting |
NCT04052867 -
Intravenous Lignocaine Infusion in Laparoscopic Donor Nephrectomy
|
N/A | |
| Recruiting |
NCT03114826 -
Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients
|
N/A | |
| Completed |
NCT02587052 -
A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis, GenTac
|
||
| Completed |
NCT02020642 -
Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx)
|
N/A | |
| Completed |
NCT01435291 -
AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation
|
Phase 4 | |
| Recruiting |
NCT01001065 -
Association of the Intrarenal Resistance Index (RI) of Transplanted Kidneys With Generalized Atherosclerosis
|
N/A | |
| Completed |
NCT00978965 -
Identification of Patients With High Probability of Poorly Responding to Therapy With Mycophenolic Acid Prodrugs
|
||
| Recruiting |
NCT00903188 -
Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
|
Phase 4 | |
| Completed |
NCT00400400 -
Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
|
Phase 4 |