Renal Failure Clinical Trial
— S&LOfficial title:
Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen: A Multicentre Prospective Randomized Controlled Study
Verified date | August 2022 |
Source | Technische Universität Dresden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to demonstrate non-inferiority of an advagraf based immunosuppressive regimen with slower dose tapering and lower starting dose of Advagraf compared with a standard Advagraf-based immunosuppressive regimen in de novo renal transplantation. Non inferiority will be assessed by a combined study endpoint consisting of the development of biopsy-proven rejection of BANFF class Ia or higher and/or graft loss and/or patient death within the first six months after renal transplantation.
Status | Active, not recruiting |
Enrollment | 400 |
Est. completion date | December 2025 |
Est. primary completion date | February 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - male or female allograft recipients at least 18 years old - primary or secondary kidney transplantation - deceased or living donor - normal immunological risk profile (PRA level > 20%, AB0-compatible donation, negative crossmatch) - informed consent of the patient Exclusion Criteria: - graft loss due to severe rejection within the first year after transplantation (in case of secondary transplantation) - multi-organ recipient - patients receiving a kidney from a non-beating donor - complete human leukocyte antigen (HLA)-identical living donor (twins) - patients with a history of malignancy during the last five years (except squamous or basal cell carcinoma of the skin after successful treatment) - patients with uncontrolled infectious disease, particularly patients who are HIV-positive or suffer from chronic hepatitis B or C or tuberculosis - patients with severe gastroenteric disorder, particularly severe diarrhea and symptoms of enteric malabsorption - patients suffering from liver cirrhosis CHILD B or C or other severe liver disease (aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), GammaGT = 3-fold increased) - thrombopenia < 70,000/mm3 - leukopenia < 2,500/mm3 - participation in another clinical trial within the last 4 weeks prior to inclusion - estimated addiction or other disorders that do not allow the person concerned, the nature and scope and possible consequences of the clinical trial - pregnant or breast-feeding women - women of childbearing age, except women who meet any of the following criteria: post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum > 40 U/ml, postoperatively (6 weeks after bilateral oophorectomy with or without hysterectomy), regular and correct use of a contraceptive method with error rate < 1 % per year (e. g. implants, depot injections, oral contraceptives, intrauterine device IUD), sexual abstinence, vasectomy of the partner - evidence that the patient is likely to fail to comply with the protocol (e. g. lack of cooperation) - hypersensitivity to Advagraf or a product listed in the prescribing information other component as well as to other macrolides |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Carl Gustav Carus | Dresden |
Lead Sponsor | Collaborator |
---|---|
Technische Universität Dresden |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Combined endpoint: defined as biopsy-proven acute rejection, graft loss or death between the groups at month 6 post-transplantation in renal transplantation) | combined endpoint: defined as biopsy-proven acute rejection, graft loss or death between the groups at month 6 post-transplantation in renal transplantation | 6 months after transplantation | |
Secondary | Rate of necessary dose modifications to achieve Advagraf target levels in early post-op period | rate of necessary dose modifications in order to achieve Advagraf target levels in the early postoperative period | 6 months after transplantation | |
Secondary | Improved renal transplant function in the early postoperative period and 6 months post-op | renal function defined by need for renal replacement therapy as well as by means of glomerular filtration rate | 6 months after transplantation | |
Secondary | Lower incidence of delayed graft function (DGF) | rate of DGF defined as need for at least one postoperative hemodialysis | 6 months after transplantation | |
Secondary | Reduced incidence of new onset diabetes after renal Transplantation (NODAT) | incidence of NODAT. Diabetes mellitus defined by American Diabetes Association - Guidelines 2016 | 6 months after transplantation | |
Secondary | Reduced rates of infection | incidence of viral or other infections | 6 months after transplantation | |
Secondary | Incidence of malignancies | incidence rate of biopsy proven malignancies | 6 months after transplantation | |
Secondary | Incidence of fractures | incidence rate of radiography or clinically proven fractures | 6 months after transplantation | |
Secondary | Incidence of heart failure | incidence rate of heart failure | 6 months after transplantation | |
Secondary | Incidence of myocardial infarction | incidence rate of myocardial infarction | 6 months after transplantation | |
Secondary | Incidence of venous thrombosis | incidence rate of venous thrombosis proven by color-coded duplex sonography or radiography | 6 months after transplantation | |
Secondary | Incidence of peripheral vascular disease | incidence rate of peripheral vascular disease, sonography or radiography proven | 6 months after transplantation | |
Secondary | Incidence of cerebrovascular disease | incidence rate of cerebrovascular disease, sonography or radiography proven | 6 months after transplantation | |
Secondary | Incidence of hypercholesterolemia | hypercholesterolemia is defined as > upper limit of normal and measured in mmol/L | 6 months after transplantation | |
Secondary | Incidence of hypertriglyceridemia | hypertriglyceridemia is defined as > upper limit of normal and measured in mmol/L | 6 months after transplantation | |
Secondary | Incidence of hyperlipoproteinemia | hyperlipoproteinemia is defined as low density lipoproteins cholesterol > upper limit of normal and measured in mmol/L | 6 months after transplantation | |
Secondary | Incidence of hypolipoproteinemia | hypolipoproteinemia is defined as high density lipoproteins cholesterol < lower limit of normal and measured in mmol/L | 6 months after transplantation | |
Secondary | Incidence of dyslipidemia | dyslipidemia is defined as low density lipoproteins cholesterol > upper limit of normal and high density lipoproteins cholesterol < lower limit of normal and each measured in mmol/L | 6 months after transplantation | |
Secondary | Incidence of arterial hypertension | blood pressure is measured in mm of mercury (mmHg) and arterial hypertension is defined according to the American College of Cardiology 2017 Guideline for High Blood Pressure in Adults | 6 months after transplantation | |
Secondary | Incidence of anemia | anemia is defined as hemoglobin level or erythrocyte count < lower limit of normal and measured in mmol/L or Tpt/L respective | 6 months after transplantation | |
Secondary | Incidence of cardiovascular mortality | cardiovascular mortality is defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident | 6 months after transplantation | |
Secondary | Chronic humoral rejection | Rate of biopsy proven chronic humoral rejections | 6 months after transplantation | |
Secondary | Interstitial fibrosis and tubular atrophy as histological changes in renal transplant biopsies | interstitial fibrosis and tubular atrophy are expressed as percentage in biopsy reports | 6 months after transplantation | |
Secondary | Incidence of polyomavirus nephropathy | polyomavirus nephropathy is defined by simian virus 40 (SV40) positive histological staining in renal transplant biopsies | 6 months after transplantation | |
Secondary | Recurrence rate of the underlying kidney disease requiring renal transplantation | Biopsy proven recurrence of the underlying disease | 6 months after transplantation | |
Secondary | Rate of donor-specific antibodies | rate of donor-specific antibodies | 6 months after transplantation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02763410 -
Impact of the Composition of Packed Red Blood Cell Supernatant on Renal Dysfunction and Posttransfusion Immunomodulation
|
||
Active, not recruiting |
NCT03183245 -
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
|
Phase 3 | |
Completed |
NCT04084301 -
Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury
|
N/A | |
Completed |
NCT03292029 -
Pilot Medical Evaluation of the T50 Test
|
N/A | |
Suspended |
NCT04589065 -
SCD for CRS in Congestive Heart Failure (CHF) (No Left Ventricular Assist Device)
|
N/A | |
Completed |
NCT03806998 -
Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure
|
Phase 3 | |
Completed |
NCT02325726 -
RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery.
|
N/A | |
Completed |
NCT02116270 -
Accelerated Immunosenescence and Chronic Kidney Disease
|
N/A | |
Completed |
NCT01859273 -
Adherence Enhancement for Renal Transplant Patients
|
N/A | |
Completed |
NCT01388270 -
Effect of a Pre Heparin Coated Dialysis Filter on Coagulation During Hemodialysis
|
Phase 4 | |
Completed |
NCT00966615 -
The Effect of Neutral Peritoneal Dialysis (PD) Solution With Minimal Glucose-Degradation-Product (GDP) on Fluid Status and Body Composition
|
Phase 4 | |
Completed |
NCT01187953 -
Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacroâ„¢ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx
|
Phase 3 | |
Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A | |
Completed |
NCT01008631 -
The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers
|
N/A | |
Completed |
NCT00765661 -
Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients
|
Phase 2 | |
Completed |
NCT00737672 -
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
|
Phase 3 | |
Completed |
NCT00808691 -
Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit
|
N/A | |
Recruiting |
NCT00470769 -
The Efficacy of Color-Doppler Ultrasonography to Assess the Renal Blood Flow With the Estimation of GFR
|
N/A | |
Terminated |
NCT00338455 -
Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC
|
Phase 2 | |
Completed |
NCT03917186 -
Desflurane vs. Sevoflurane in Endovascular Aortic Repair
|
Phase 4 |