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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01649427
First received: July 20, 2012
Last updated: October 23, 2015
Last verified: October 2015
  Purpose
The purpose of this study is to investigate if Tacrolimus Hexal® has similar pharmacokinetic properties compared to Prograf® in de novo renal transplant patients and whether the comparable exposure results in similar renal function.

Condition Intervention Phase
Pharmacokinetics Study in de Novo Kidney Transplantation
Drug: Simulect
Drug: Steroids
Drug: Prograf
Drug: Tacrolimus Hexal
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • measured by dose normalized AUC 0-12 h [ Time Frame: During the first month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of BPAR, graft loss or death [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    safety and tolreability during 12 month


Enrollment: 76
Study Start Date: October 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PHASE I
In a first phase of the study, pharmacokinetic parameters will be evaluated with a total of 60 evaluable patients (30 patients per treatment group).One Group on Prograf, the other on Tacrolimus Hexal
Drug: Simulect
Induction Therapy: 2x20mg; day 0 and day 4 post Tx
Other Name: Basiliximab
Drug: Steroids
recommended on Day 14 after transplantation steroid dose is reduced to 5 mg prednisolon or eqivalent. A minimum dose of 5 mg prednisolon or equivalent should be continued until Month 6.
Other Name: prednisolon
Drug: Prograf
0.15 mg/KG Transplantation to Month 1: 8 - 12 ng/ml Month 1 to Month 3: 5 - 10 ng/ml Month 3 to Month 6: 5 - 8 ng/ml
Experimental: Prograf
After initial Phase 1 Phase two follows until month 12. Group 1 up to 163 pts. on Prograf
Drug: Steroids
recommended on Day 14 after transplantation steroid dose is reduced to 5 mg prednisolon or eqivalent. A minimum dose of 5 mg prednisolon or equivalent should be continued until Month 6.
Other Name: prednisolon
Drug: Prograf
0.15 mg/KG Transplantation to Month 1: 8 - 12 ng/ml Month 1 to Month 3: 5 - 10 ng/ml Month 3 to Month 6: 5 - 8 ng/ml
Experimental: Tacroliums Hexal
After initial Phase 1 Phase two follows until month 12. Group 2 up to 163 pts. on Tacrolimus Hexal
Drug: Steroids
recommended on Day 14 after transplantation steroid dose is reduced to 5 mg prednisolon or eqivalent. A minimum dose of 5 mg prednisolon or equivalent should be continued until Month 6.
Other Name: prednisolon
Drug: Tacrolimus Hexal
0.15 mg-Kg Transplantation to Month 1: 8 - 12 ng/ml Month 1 to Month 3: 5 - 10 ng/ml Month 3 to Month 6: 5 - 8 ng/ml
Experimental: Immunosupressive Drug Drug: Simulect
Induction Therapy: 2x20mg; day 0 and day 4 post Tx
Other Name: Basiliximab

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649427

Locations
Germany
Novartis Investigative Site
Berlin, Germany, 10098
Novartis Investigative Site
Bochum, Germany, 44892
Novartis Investigative Site
Duesseldorf, Germany, 40225
Novartis Investigative Site
Kaiserslautern, Germany, 67655
Novartis Investigative Site
Koeln-Merheim, Germany, 51109
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01649427     History of Changes
Other Study ID Numbers: CERL080ADE27 
Study First Received: July 20, 2012
Last Updated: October 23, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Pharmacokinetics Study
Tacroliums
GFR
kdney

Additional relevant MeSH terms:
Tacrolimus
Basiliximab
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 24, 2016