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

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ClinicalTrials.gov Identifier: NCT01649427
Recruitment Status : Completed
First Posted : July 25, 2012
Results First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE July 20, 2012
First Posted Date  ICMJE July 25, 2012
Results First Submitted Date  ICMJE August 19, 2016
Results First Posted Date  ICMJE June 17, 2019
Last Update Posted Date June 17, 2019
Actual Study Start Date  ICMJE October 17, 2012
Actual Primary Completion Date August 20, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
  • measured by dose normalized AUC 0-12 h [ Time Frame: During the first month ]
    PHASE I: To demonstrate that the pharmacokinetics of Tacrolimus Hexal® assessed by the ratio of the AUC0-12h over a one month period post-transplantation is comparable to Prograf® in renal transplant patients.
  • Change of GFR over time and between the two groups [ Time Frame: at Baseline and month 6 ]
    PHASE II To demonstrate non-inferiority in renal function measured by glomerular filtration rate GFR(Nankivell formula) between both treatment arms at month 6 post-transplantation in renal transplant patients.
Change History Complete list of historical versions of study NCT01649427 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • 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.
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
Number of BPAR, graft loss or death [ Time Frame: 12 month ]
safety and tolerability during 12 month
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients
Official Title  ICMJE 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
Brief 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pharmacokinetics Study in de Novo Kidney Transplantation
Intervention  ICMJE
  • Drug: Prograf
    Prograf® capsules were supplied as capsules of 0.5 mg, 1 mg and 1.5 mg dose strengths.
  • Drug: Tacrolimus Hexal

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

    1 mg and 1.5 mg.

Study Arms  ICMJE
  • Experimental: Prograf
    Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
    Intervention: Drug: Prograf
  • Experimental: Tacroliums Hexal
    Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
    Intervention: Drug: Tacrolimus Hexal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2019)
73
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2012)
326
Actual Study Completion Date  ICMJE August 20, 2015
Actual Primary Completion Date August 20, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01649427
Other Study ID Numbers  ICMJE CERL080ADE27
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP