Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients

NCT02432833 | Completed Phase 4

• 2 other identifiers: CCD-06235AA1-012014-004314-29
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare tacrolimus dosing of the new Envarsus®-based immunosuppressive regimen with current clinical practice (Prograf or Advagraf) over 6 months following de novo renal transplantation in a real-life setting in different European Countries.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Tacrolimus total daily dose (TDD) from week 3 to month 6

  from week 3 to month 6

Secondary Outcomes (7)

• Tacrolimus blood trough level (TL).

  from screening to months 6

• number of dose adjustment

  from screening to months 6

• Occurrence of treatment failure

  from screening to months 6

• Delayed graft function

  from screening to months 6

• Acute rejection requiring treatment

  from screening to months 6

Study Arms (2)

Envarsus® (tacrolimus)

EXPERIMENTAL

prolonged-release tablets once daily and orally

Drug: ENVARSUS®

Prograf or Advagraf

ACTIVE COMPARATOR

Prograf® hard capsules, twice daily, oral formulation or Advagraf® prolonged-release hard capsules, once daily, oral formulation

Drug: PROGRAF®; Drug: ADVAGRAF®

Interventions

ENVARSUS® DRUG

Envarsus® tablets, once daily, oral formulation. Prolonged -release formulation of tacrolimus

Envarsus® (tacrolimus)

PROGRAF® DRUG

Prograf® hard capsules, twice daily, oral formulation

Prograf or Advagraf

ADVAGRAF® DRUG

Advagraf® prolonged-release hard capsules, once daily, oral formulation

Prograf or Advagraf

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's signed informed consent obtained prior to any study-related procedure;
• Adult men and women at least 18 years of age with end-stage renal disease who are recipients (or will be recipients) of a kidney transplant from a living or deceased donor;
• No known contraindications to the administration of tacrolimus, other macrolides and study drugs excipients;
• Patients must agree to use a highly reliable method of birth control;
• Donor-recipient negative cross match test, and compatible AB0 blood type;
• Able to swallow tablets and capsules

You may not qualify if:

• Recipient of any transplanted organ other than kidney;
• Recipient of a previous renal transplant;
• Recipient of a kidney from a donor after cardiac death;
• Recipient of a kidney from an AB0 incompatible or positive cross-match donor;
• Current (not older than 3 months) anti-HLA Panel Reactive Antibody (PRA) levels higher than 30%. Whenever PRA, either complement-dependent cytotoxicity-PRA or calculated PRA , is not available, patients who are positive on solid-phase screening assay for anti-HLA antibodies must not be enrolled;
• Recipient of a kidney with a cold ischemia time of ≥ 30 hours;
• White blood cells count ≤ 2.8x109 cells/L unless ANC \>1.0x109/L;
• Platelet count \< 50 x109 cells/L;
• ALT or AST levels \>3 times the normal upper limit during the 30 days prior transplant procedure;
• Current abuse of drugs or alcohol;
• Incapable of understanding purpose and risk of study, unable to give written informed consent or unwilling to comply with study protocol;
• Treatment with any other investigational agent in the 30 days prior to enrolment;
• Kidney recipients and/or donors positive for HCV (HCV-RNA positive or HCV-Ab positive respectively);
• Kidney recipients and/or donors positive for HBV (HBV-DNA or HBS-Ag positive);
• Recipients positive for HIV;

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Chiesi farmaceutici Spa

Parma, 43123, Italy

Location

Related Publications (1)

• Budde K, Rostaing L, Maggiore U, Piotti G, Surace D, Geraci S, Procaccianti C, Nicolini G, Witzke O, Kamar N, Albano L, Buchler M, Pascual J, Gutierrez-Dalmau A, Kuypers D, Wekerle T, Glyda M, Carmellini M, Tisone G, Midtvedt K, Wennberg L, Grinyo JM. Prolonged-Release Once-Daily Formulation of Tacrolimus Versus Standard-of-Care Tacrolimus in de novo Kidney Transplant Patients Across Europe. Transpl Int. 2022 Mar 21;35:10225. doi: 10.3389/ti.2021.10225. eCollection 2022.

  PMID: 36017158 DERIVED

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Klemens Budde, MD

  Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 4, 2015
• Study Start: May 1, 2015
• Primary Completion: January 24, 2017
• Study Completion: January 24, 2017
• Last Updated: April 13, 2018

Record last verified: 2018-04

Locations

IT (1)