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

Phase 3

• Conditions: N18.8; Z94.0; Kidney transplant status

• Registration Number: DRKS00000858
• Lead Sponsor: niversitätsklinikum FreiburgKlinik für Allgemein und Vizeralchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2005-11-29
• Study Start: 2012-04-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

Exclusion Criteria

- slave- or multi-transplantation
- combined transplantation
- age < 18 years
- incompatibility (allergy, intolerance, oversensitive) against study medication
- current malignant disease or last malignant disease< 5 years
- Serious intercurrent infections (uncontrolled or requiring treatment (incl. HIV)
- severe diarrhoea, vomiting or active gastric- or duodenal ulcer
- participation in another investigational sudy
- autoimmune disease as primary disease (collagen vascular diseases, colitis, HUS, SLE)
- primary disease focal-sclerotising glomerulonephritis
- disease, which need temporary or permanent treatment with cortisone (also inhalatory medicines)
-severe fat metabolic disturbance (cholesterine > 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 )

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transplant function (serum creatinine mg/dl and ceatinin-clearance) after 1, 3, 5 years

Secondary Outcome Measures

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