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Prospective Institutional review trial to test de novo sirolimus monotherapy following antithmocyte globin induction in kidney transplant recipients

Prospective Institutional review trial to test de novo sirolimus monotherapy following antithmocyte globin induction in kidney transplant recipients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00000858
Enrollment
15
Registered
2012-04-25
Start date
2005-01-26
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

N18.8 Z94.0

Interventions

Group 1: 15 well-selected immunologically low-risk patients receive a minimized immunsuppressive regime after kidney transplantation. The immunsupression starts with antithymocyte globin induction fol

Sponsors

Universitätsklinikum Freiburg Klinik für Allgemein und Vizeralchirurgie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: - first kidney transplantation - ager 18 - 65 years - Written informed consent - Highly effective contraception

Exclusion criteria

Exclusion criteria: - slave- or multi-transplantation - combined transplantation - age 300 mg/dl, triglycerides > 400 mg/dl) - Epstein-Barr-virus IgG negative - chronic hepatitis B and hepatitis C infection - thrombocytopenia < 50.000 tsd/µl -coagulopathies ( lack of or a defect in v. Willebrand factor, hemophilia, lack of protein S lack of protein C )

Design outcomes

Primary

MeasureTime frame
Transplant function (serum creatinine mg/dl and ceatinin-clearance) after 1, 3, 5 years

Secondary

MeasureTime frame
• patient- and transplant survival • rate and degree of acute bioptic confirmed graft shedding(after Banff) and number of steroid-resistant sheddings • intake of calcineurin-inhibitors • steroid long-term medication • incidence of Chronic Allograft Nephropathy (CAN) • level of blodd pressure and antihypertensive medication • lipid level and lipid reducing medication • liver function • rate and degree of oppertunistic infections • incidence of an haematological adverse effect • incidence of malignant disease

Countries

Germany

Contacts

Public ContactOliver Thomusch

Abt. Allgemein- und Viszeralchirurgie

oliver.thomusch@uniklinik-freiburg.de0761-270-28580

Outcome results

None listed

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