Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen

• Status: Active, not recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität Dresden
• Treatments: Immunosuppressive Agents; Tacrolimus

Criteria

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