6 month, multi-center, open-label, prospective, randomized trial, investigating a standard regimen of an advagraf based immunosuppressive regimen in de-novo renal transplant patients versus a slower dose tapering and lower starting dose of Advagraf

6 month, multi-center, open-label, prospective, randomized trial, investigating a standard regimen of an advagraf based immunosuppressive regimen in de-novo renal transplant patients versus a slower dose tapering and lower starting dose of Advagraf - Slow and low

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001770-19-DE

Enrollment

400

Registered

2014-05-12

Start date

2014-09-01

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients, waiting for first or second renal transplantation de novo kidney transplant patients MedDRA version: 20.0 Level: LLT Classification code 10038474 Term: Renal insufficiency System Organ Class: 100000004857

Interventions

Trade Name: Advagraf Pharmaceutical Form: Capsule, hard INN or Proposed INN: Tacrolimus Other descriptive name: TACROLIMUS MONOHYDRATE C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female allograft receipients at least 18 years old 2. primary or secondary kidney transplantation 3. deceased or living dondor 4. normal immunological risk profile, • PRA level > 20%, • AB0-comaptible donation, • negative Crossmatch 5. informed consent of the Patient 6. Allowance to contact the familys doctor and/or neprologist for study relevant data Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 280 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: 1. Graft loss due to severe rejection within the first year after transplantation (in case of secondary transplantation) 2. Multi- organ recepient 3. Patients receiving a kidney from a non beating donor 4. Complete HLA-identical living donor (twins) 5. Patients with a history of malignancy during the last five years ( except squamous or basal cell carcinoma of the skin after successful treatment) 6. Patients with uncontrolled infectious disease, particularly patients who are HIV positiv or suffer from chronic hepatitis B or C or tuberculosis 7. Patients with severe gastroenteric disorder, particularly severe diarrhoe and symptoms of enteric malabsorption 8. Patients suffering from liver cirrhosis Child B or C or other severe liver disease (ASAT, ALAT, GammaGT = 3-fold increased) 9. Thrombopenia 40 U / ml) - Postoperatively (6 weeks after bilateral oophorectomy withor without hysterectomy) - Regular and correct use of a contraceptive method with error rate <1% per year (eg implants, depot injections, oral contraceptives, intrauterine device IUD); Sexual abstinence - vasectomy of the partner 15. Evidence that the patient is likely to fail to comply with the protocol (eg lack of cooperation) 16. Hypersensitivity to tacrolimus or a product listed in the prescribing information other component as well as to other macrolides

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate non-inferiority of biopsy-proven rejection of Banff class Ia or higher and/or graft loss and/or patient death in the study group with slower dose tapering and lower starting dose of Advagraf compared with an standard Advagraf based immunosuppressive regimen.; Secondary Objective: To assess - Rate of necessary dose modifications in order to achieve tacrolimus target levels in the early postoperative period - Renal function defined by need for renal replacement therapy as well as by means of glomerular filtration rate - Rate of DGF defined as necessity for at least one postoperative hemodialysis - Incidence of viral and other infections - Incidence of NODAT • Incidenz of - malignant tumors - fractures - heart failures - myocardial infarction - venous thrombosis - peripheral- and cerebrovaskular diseases - hyperlipoproteinemia - arterial hypertension - anemias • Rate of chronic-humoral rejektions ;Primary end point(s): combined endpoint: , defined as biopsy-proven acute rejection, graft loss or death between the groups at month 6 post-transplantation in renal transplantation;Timepoint(s) of evaluation of this end point: 6 month post transplantation	—

Measure

Time frame

Main Objective: To demonstrate non-inferiority of biopsy-proven rejection of Banff class Ia or higher and/or graft loss and/or patient death in the study group with slower dose tapering and lower starting dose of Advagraf compared with an standard Advagraf based immunosuppressive regimen.; Secondary Objective: To assess - Rate of necessary dose modifications in order to achieve tacrolimus target levels in the early postoperative period - Renal function defined by need for renal replacement therapy as well as by means of glomerular filtration rate - Rate of DGF defined as necessity for at least one postoperative hemodialysis - Incidence of viral and other infections - Incidence of NODAT • Incidenz of - malignant tumors - fractures - heart failures - myocardial infarction - venous thrombosis - peripheral- and cerebrovaskular diseases - hyperlipoproteinemia - arterial hypertension - anemias • Rate of chronic-humoral rejektions ;Primary end point(s): combined endpoint: , defined as biopsy-proven acute rejection, graft loss or death between the groups at month 6 post-transplantation in renal transplantation;Timepoint(s) of evaluation of this end point: 6 month post transplantation

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Secondary

Measure	Time frame
Secondary end point(s): - Rate of necessary dose modifications in order to achieve tacrolimus target levels in the early postoperative period - renal function defined by need for renal replacement therapy as well as by means of glomerular filtration rate - Rate of DGF defined as necessity of for at least one postoperative hemodialysis - Incidence of viral or other infections - Incidence of NODAT • Incidenz of - malignant tumors - fractures - heart failures - myocardial infarction - venous thrombosis - peripheral- and cerebrovaskular diseases - hyperlipoproteinemia - arterial hypertension - anemias • Rate of chronic-humoral rejektions ; Timepoint(s) of evaluation of this end point: 5 days, 4 weeks, 2 month, 6 month, observational follow up: 3 years, 5 years after transplantation	—

Measure

Time frame

Secondary end point(s): - Rate of necessary dose modifications in order to achieve tacrolimus target levels in the early postoperative period - renal function defined by need for renal replacement therapy as well as by means of glomerular filtration rate - Rate of DGF defined as necessity of for at least one postoperative hemodialysis - Incidence of viral or other infections - Incidence of NODAT • Incidenz of - malignant tumors - fractures - heart failures - myocardial infarction - venous thrombosis - peripheral- and cerebrovaskular diseases - hyperlipoproteinemia - arterial hypertension - anemias • Rate of chronic-humoral rejektions ; Timepoint(s) of evaluation of this end point: 5 days, 4 weeks, 2 month, 6 month, observational follow up: 3 years, 5 years after transplantation

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Countries

Germany

Contacts

Public ContactKKS / Mario Graf

Technische Universität Dresden

SundL.KKS@uniklinikum-dresden.de004935145818622

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026