Adults 18 to 64, any sex, with Pharmacokinetics Study in de Novo Kidney Transplantation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
ANCOVA Model for Change in Nankivell GFR (mL/Min) at Month 6, Without Replacement of Missing Values (Full Analysis Set)Primary· baseline to month 6
Change in Nankivell glomerular filtration rate (GFR) from baseline to 6 months
Glomerular Filtration Rate (GFR): The GFR is the best clinical estimate of renal function in health and disease, and correlates well with the clinical severity of renal function disturbances. Several studies have shown that in patients with progressive renal disease, GFR declines or reciprocal serum creatinine levels elevate linearly over time in a predictable manner. With the help of the serum creatinine values, the GFR was calculated via Nankivell formula.
Group
Value
95% CI
Tacrolimus Hexal®
47.65
41.70 – 53.60
Prograf®
38.60
31.32 – 45.89
The Incidence of Biopsy-proven Acute Rejection (BPAR), Graft Loss and Death Until Month 12 (Full Analysis Set) (Full Analysis Set)Secondary· baseline to month 12
The key secondary objective was to assess the incidence of individual endpoints BPAR, graft loss and death until month 6 post-transplantation.
Biopsy proven acute rejection (BPAR)
Group
Value
95% CI
Tacrolimus Hexal®
2
0.70 – 19.16
Prograf®
3
1.66 – 21.38
Graft loss
Group
Value
95% CI
Tacrolimus Hexal®
0
0.00 – 10.00
Prograf®
1
0.07 – 13.81
Death
Group
Value
95% CI
Tacrolimus Hexal®
0
0.00 – 10.00
Prograf®
1
0.07 – 13.81
Composite: BPAR, graft loss or death
Group
Value
95% CI
Tacrolimus Hexal®
2
0.70 – 19.16
Prograf®
4
2.94 – 24.80
ANCOVA Model for Change in CKD-EPI GFR (Chronic Kidney Disease Epidemiology Collaboration Glomerular Filtration Rate) at Month 6 Post-transplantationSecondary· baseline to Month 6
ANCOVA model for change in CKD-EPI Glomerular Filtration Rate (GFR)\[ml/min\] without replacement of missing values
Group
Value
95% CI
Tacrolimus Hexal®
48.33
± 3.84
Prograf®
39.77
± 4.61
ANOVA for Dose-normalized Tacrolimus 12-h-AUC (h/103*L) at Month 1Primary· end of month 1
Compares the PK of Tacrolimus Hexal® assessed by the ratio of the AUC0-12h over one month period post transplantation vs. Prograf® in renal transplant patients
Adjusted, log-transformed Estimates (ANOVA)
Group
Value
95% CI
Tacrolimus Hexal®
2.944
2.783 – 3.105
Prograf®
3.020
2.811 – 3.228
Adjusted, back-transformed Estimates (ANOVA)
Group
Value
95% CI
Tacrolimus Hexal®
18.991
16.163 – 22.314
Prograf®
20.484
16.630 – 25.231
ANCOVA Model for Change in MDRD GFR (ml/Min) at Month 6, Without Replacement of Missing ValuesSecondary· least square (LS) mean change from baseline to Month 6
MDRD GFR
Group
Value
95% CI
Tacrolimus Hexal®
46.20
37.62 – 54.79
Prograf®
38.52
28.64 – 48.41
ANCOVA Model for Change in Cockcroft-Gault GFR (ml/Min) at Month 6, Without Replacement of Missing ValuesSecondary· least square (LS) mean change from baseline to Month 6
change in Cockcroft-Gault GFR
Group
Value
95% CI
Tacrolimus Hexal®
60.45
52.48 – 68.41
Prograf®
46.45
36.89 – 56.02
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 17 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01649427.