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The course of therapy, safety and pharmacokinetic parameters of conversion of Prograf® to Tacrolimus Hexal®/Crilomus® in renal transplant recipients – an observational study in Germany

The course of therapy, safety and pharmacokinetic parameters of conversion of Prograf® to Tacrolimus Hexal®/Crilomus® in renal transplant recipients – an observational study in Germany

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00009364
Enrollment
200
Registered
2015-09-21
Start date
2014-08-11
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

Prophylaxis of graft rejection

Interventions

Group 1: Tacrolimus HEXAL®/Crilomus® is used following the instructions in Ch. 4.2 of the summary of product characteristics. The study documents routinely collected clinical data and laboratory value

Sponsors

Hexal AG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - male and female patients >=18 - written informed consent - time elapsed after Transplantation >= 6 month - conversion from Prograf® to Tacrolimus HEXAL®/Crilomus® - stable function of graft (S-Creatinine <3,5 mg/dL or <310 µmol/l)

Exclusion criteria

Exclusion criteria: - Patient participating in interventional Trial - known missing compliance of the Patient - acute rejection during last 3 months or antibody medeated therapy against rejection during the last 6 month - known active CMV or BKV replication - active malignancies except basalioma or non-malignant Skin tumours - known contraindication against application of Tacrolimus HEXAL®/Crilomus® according to SMPC - for female patients: pregnancy or breast-feeding

Design outcomes

Primary

MeasureTime frame
Extension of the available information of the therapy with Tacrolimus HEXAL®/Crilomus® in routine clinical practice

Secondary

MeasureTime frame
Extension of available information on death, graft rejection, ofter conversion from Prograf to Tacrolimus HEXAL®/Crilomus®; extension of the available information on the tolerability profile of Tacrolimus HEXAL®/Crilomus®: documentation of adverse events

Countries

Germany

Contacts

Public ContactCaroline Schneider

Institut Dr. Schauerte

info@dr-schauerte.de089-641804-0

Outcome results

None listed

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