Phase 4
Completed N=73
Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients
Pharmacokinetics Study in de Novo Kidney Transplantation
Source: ClinicalTrials.gov NCT01649427 ↗
Enrolled (actual)
73
Serious AEs
48.7%
Results posted
Jun 2019
Primary outcomePrimary: ANCOVA Model for Change in Nankivell GFR (mL/Min) at Month 6, Without Replacement of Missing Values (Full Analysis Set) — 47.65; 38.60 mL/min — p=0.0003
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study was to investigate if Tacrolimus Hexal® has similar pharmacokinetic properties compared to Prograf® in de novo renal transplant patients and whether the comparable exposure resulted in similar renal function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ANCOVA Model for Change in Nankivell GFR (mL/Min) at Month 6, Without Replacement of Missing Values (Full Analysis Set) |
47.65; 38.60 | 0.0003 sig |
| PRIMARY ANOVA for Dose-normalized Tacrolimus 12-h-AUC (h/103*L) at Month 1 |
2.944; 3.020; 18.991; 20.484 | — |
| SECONDARY The Incidence of Biopsy-proven Acute Rejection (BPAR), Graft Loss and Death Until Month 12 (Full Analysis Set) (Full Analysis Set) |
2; 3; 0; 1; 0; 1 | — |
| SECONDARY ANCOVA Model for Change in CKD-EPI GFR (Chronic Kidney Disease Epidemiology Collaboration Glomerular Filtration Rate) at Month 6 Post-transplantation |
48.33; 39.77 | — |
| SECONDARY ANCOVA Model for Change in MDRD GFR (ml/Min) at Month 6, Without Replacement of Missing Values |
46.20; 38.52 | — |
| SECONDARY ANCOVA Model for Change in Cockcroft-Gault GFR (ml/Min) at Month 6, Without Replacement of Missing Values |
60.45; 46.45 | — |
Eligibility Criteria
Inclusion:
primary or sec. kidney transplanted patiens, written consent, cold ischemia 20%, Antibodys against HLA-type of donor organ, hypersensitivity against Tacro or MMF,
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01649427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.