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

NCT01649427 | Completed Phase 4 Results DMC

• 1 other identifier: CERL080ADE27
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 5

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.

Conditions

Pharmacokinetics Study in de Novo Kidney Transplantation

Keywords

Pharmacokinetics Study; Tacroliums; GFR; kidney; transplant rejection; allograft rejection; xenograft rejection; host vs graft disease; renal transplant

Outcome Measures

Primary Outcomes (2)

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

  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.

  baseline to month 6

• ANOVA for Dose-normalized Tacrolimus 12-h-AUC (h/103*L) at 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

  end of month 1

Secondary Outcomes (4)

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

  baseline to month 12

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

  baseline to Month 6

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

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

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

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

Study Arms (2)

Prograf

EXPERIMENTAL

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®

Drug: Prograf

Tacroliums Hexal

EXPERIMENTAL

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®

Drug: Tacrolimus Hexal

Interventions

Prograf DRUG

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

Prograf

Tacrolimus Hexal DRUG

Tacrolimus Hexal® capsules were supplied to the investigators at dose strengths of 0.5 mg, 1 mg and 1.5 mg.

Tacroliums Hexal

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (5)

Novartis Investigative Site

Berlin, 10098, Germany

Location

Novartis Investigative Site

Bochum, 44892, Germany

Location

Novartis Investigative Site

Düsseldorf, 40225, Germany

Location

Novartis Investigative Site

Kaiserslautern, 67655, Germany

Location

Novartis Investigative Site

Koeln-Merheim, 51109, Germany

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Limitations and Caveats

1 patient was randomized to Prograf but didn't get treatment and was excluded from efficacy analyses but kept for safety reporting. Phase 2 was not started due to high drop-out rate. 73 enrolled; 43 of the planned 54 were available for PK analysis

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

(862) 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 25, 2012
• Study Start: October 17, 2012
• Primary Completion: August 20, 2015
• Study Completion: August 20, 2015
• Last Updated: June 17, 2019
• Results First Posted: June 17, 2019

Record last verified: 2017-11

Locations

DE (5)