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Completed

NCT Number: NCT01649427

Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients

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.

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Key information

Conditions

Pharmacokinetics Study in de Novo Kidney Transplantation Graft vs Host Disease Immune System Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Berlin, Germany

Loading trial locations.

About this study

In Phase II of this study there was a high patient drop-out rate and an associated long recruitment timespan. Eighty-one patients were recruited to Phase I and only 45 of the required 54 patients were available for PK analysis. To complete Phase II, 245 (in addition to 81) patients were to be required to achieve calculated sample size. Therefore the protocol was amended to stop recruitment and analyze Phase I patient data of CERL080ADE27 (PK-Phase I). Patients that were still ongoing were scheduled for an end of study (EOS) visit. During this visit patients were informed by the investigator about the end of study and advised about further treatment course.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

primary or sec. kidney transplanted patiens, written consent, cold ischemia < 24 h

Exclusion:

multi organ, immunological risc pts., PRA >20%, Antibodys against HLA-type of donor organ, hypersensitivity against Tacro or MMF,

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Prograf

Drug

Prograf® capsules were supplied as capsules of 0.5 mg, 1 mg and 1.5 mg dose strengths.

Tacrolimus Hexal

Drug

Tacrolimus Hexal® capsules were supplied to the investigators at dose strengths of 0.5 mg,

1 mg and 1.5 mg.

Primary outcomes

  1. ANCOVA Model for Change in Nankivell GFR (mL/Min) at Month 6, Without Replacement of Missing Values (Full Analysis Set)

    Time frame: 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.

  2. ANOVA for Dose-normalized Tacrolimus 12-h-AUC (h/103*L) at Month 1

    Time frame: 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

Secondary outcomes

  1. The Incidence of Biopsy-proven Acute Rejection (BPAR), Graft Loss and Death Until Month 12 (Full Analysis Set) (Full Analysis Set)

    Time frame: 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.

  2. ANCOVA Model for Change in CKD-EPI GFR (Chronic Kidney Disease Epidemiology Collaboration Glomerular Filtration Rate) at Month 6 Post-transplantation

    Time frame: baseline to Month 6

    ANCOVA model for change in CKD-EPI Glomerular Filtration Rate (GFR)[ml/min] without replacement of missing values

  3. ANCOVA Model for Change in MDRD GFR (ml/Min) at Month 6, Without Replacement of Missing Values

    Time frame: least square (LS) mean change from baseline to Month 6

    MDRD GFR

  4. ANCOVA Model for Change in Cockcroft-Gault GFR (ml/Min) at Month 6, Without Replacement of Missing Values

    Time frame: least square (LS) mean change from baseline to Month 6

    change in Cockcroft-Gault GFR

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients

Acronym: Spartacus

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 25, 2012
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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