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Kidney TransplantationPhase 2NCT02970630

Envarsus® Once Daily With Everolimus in Elderly Kidney Transplant Recipients: Pharmacokinetic and Clinical Study

A Phase 2 study testing Tacrolimus and Everolimus in people with Kidney Transplantation, run by Chiesi Farmaceutici S.p.A. at 6 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective, single-arm, open-label, multicentre study with the principal aim to estimate tacrolimus pharmacokinetic parameters in elderly de-novo kidney transplant recipients of ECD (Extended Criteria Donor) kidney grafts treated with Envarsus® prolonged release tablets in combination with everolimus tablets. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Kidney Transplantation
What is being tested?
Tacrolimus and Everolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
6 sitesItaly
Study dates
Jan 2017to 22 Feb 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject's written informed consent obtained prior to transplant intervention and prior to any study-related procedures;
  • Caucasian male or female subjects aged 60 or older who are receiving a primary or secondary single or dual renal transplant from a blood group compatible deceased donor;
  • Patients who are planned to receive a renal allograft by Extended Criteria Donor (ECD);
  • Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study;
  • Patients with low to standard immunological risk, who had a PRA (Panel Reactive Antibody) ≤ 20% (PRA testing according to centre's practice);
  • Body Mass Index (BMI) between 15 and 35 kg/m2 extremes inclusive;
  • Women must be postmenopausal (physiologic menopause defined as "12 consecutive months of amenorrhea") or permanently sterilized (e.g. tubal occlusion, hysterectomy or bilateral salpingectomy) to be enrolled in the study.

Who cannot join

  • Recipients of any transplanted organ other than a single or dual kidney;
  • Patients unable or unwilling to provide informed consent;
  • Male subjects with females partner of childbearing potential UNLESS they or their partner are willing to use a reliable method of contraception (see below for details) from the time of first dose administration and until 8 weeks after the last dose of study drugs. Male subjects with partners of non-childbearing potential are not required to use contraception.
  • Reliable methods of contraception for male subjects and their partner of childbearing potential must be one of the following:
  • Placement of an intrauterine device or intrauterine system
  • Hormonal contraception (implantable, patch, oral)
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  • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical vaults/caps) with spermicidal foam/gel/film/cream/suppository.
  • Male sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate "True abstinence" is acceptable only if it is in line with the preferred and usual lifestyle of the subject.
  • Recipients of a bone marrow or stem cell transplant;
  • Recipients of a kidney from a cardiac death donor;
  • Recipients of a kidney from an ABO (0, A and blood cell types) incompatible donor;
  • Recipients having pre-transplant donor specific anti-HLA (Human leukocyte antigen antibodies) (DSA) or who lost the first kidney transplant because of acute rejection;
  • Recipients of a kidney with an anticipated cold ischemia time ≥ 24 hours;
  • Recipients positive for Hepatitis C virus (HCV-RNA positive) and/or Hepatitis B Virus (HBV-DNA or HBsAg positive);
  • Recipients positive for Human Immunodeficiency Virus (HIV-Ab positive);
  • Patients with a current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully;
  • Patients with uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives;
  • Patients with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of study drugs;
  • Patients with a white blood cell count ≤ 2.8x109/L unless the absolute neutrophil count (ANC) is ≥ 1.0x109/L;
  • Patients with a platelet count ≤ 50.0x109/L;
  • Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) enzyme levels > 3 times the upper limit of normal during the 30 days prior to the transplant procedure;
  • Patients who were treated with any other investigational agent in the three months prior to enrolment;
  • Patients who received any investigational new drug, or participated in clinical study within the last 8 weeks;
  • Patient planned to receive an induction therapy different from rabbit ATG (Anti-thymocyte globulin) alone or patients who did not start rabbit ATG induction therapy after transplant;
  • Patients who are already on immunosuppressive drugs the day before transplantation, except ATG as per protocol;
  • Patients who are planned to receive therapy with any immunosuppressive agent other than those prescribed in the study;
  • Patients with a known hypersensitivity to corticosteroids, tacrolimus or everolimus or sirolimus or any of the excipients present in study drugs formulations;
  • Patients with hypersensitivity to macrolides;
  • Patients with any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator;
  • Subjects unlikely to comply with the study protocol or unable to understand the nature and scope of the study but also the possible benefits or unwanted effects of the study treatments;
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Italy6 sites

  • Ospedale Ca' Granda - Niguarda

    Milan

  • Ospedale Maggiore Policlinico

    Milan

  • Azienda Ospedaliera di Padova

    Padova

  • Policlinico "A. Gemelli"

    Rome

  • Policlinico "Le Scotte"

    Siena

  • Azienda Ospedaliera S. Giovanni Battista

    Torino

Other trials in Italy

About this study

Official title: Envarsus® Tablets Administered Once Daily in Combination With Everolimus in Elderly De-novo Kidney Transplant Recipients: Open-label, Multicentre, Single-arm, Pharmacokinetic and Clinical Study

Prospective, single-arm, open-label, multicentre study with the principal aim to estimate tacrolimus pharmacokinetic parameters in elderly de-novo kidney transplant recipients of ECD (Extended Criteria Donor) kidney grafts treated with Envarsus® prolonged release tablets in combination with everolimus tablets.

Being tested
Tacrolimus, Everolimus
Keywords
prophylaxis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02970630
Study groupRoleWhat they receive
Envarsus once a day, everolimus b.i.d.ExperimentalTacrolimus tablets at starting dose of 0.07 mg/kg/day will be administered once daily in the morning. Everolimus tablets at starting dose of 2 mg/day (1 mg b.i.d.) will be administered twice daily, every 12 hours.
Receives: Drug: Tacrolimus; Drug: Everolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tacrolimus Area Under the curve at 24 hours (AUC24)

    Measured: 10 days

  2. Tacrolimus Minimum whole blood concentration (Cmin)

    Measured: 10 days

  3. Tacrolimus Cmin/daily dose

    Measured: 10 days

  4. Tacrolimus AUC24/daily dose

    Measured: 10 days

Secondary outcomes (18)

  1. Tacrolimus within-patient variability of blood trough level

    Measured: from day 3 to month 6

  2. Time to reach therapeutic exposure to tacrolimus

    Measured: from day 3 to month 6

  3. Number of dose adjustments

    Measured: from day 3 to month 6

  4. Total daily dose

    Measured: from day 3 to month 6

  5. Renal function using estimated glomerular filtration rate

    Measured: from day 1 to month 6

  6. Treatment failure rate

    Measured: from day 1 to month 6

  7. Delayed graft function

    Number of days between the first and the last renal replacement session

    Measured: from day 1 to month 6

  8. Acute rejection requiring treatment

    Measured: from day 1 to month 6

  9. Biopsy proven acute rejections

    Measured: from day 1 to month 6

  10. Tacrolimus Maximum whole blood concentration (Cmax)

    Measured: 10 days

  11. Tacrolimus Tmax (time that the drug is present at the maximum concentration in serum)

    Measured: 10 days

  12. Tacrolimus Average whole blood drug concentration (Cave)

    Measured: 10 days

  13. Tacrolimus % fluctuation

    Measured: 10 days

  14. Tacrolimus % swing

    Measured: 10 days

  15. Tacrolimus linear correlation coefficient between Cmin and AUC24

    Measured: 10 days

  16. Adverse Events

    Measured: from screening to month 6

  17. Serious Adverse Events

    Measured: from screening to month 6

  18. Number of opportunistic infections

    Number of opportunistic infections

    Measured: from screening to month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2016 (estimated)
  2. Study startJan 2017
  3. Primary completion22 Feb 2018
  4. Study completion22 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02970630
Sponsor's protocol ID
DFIDM-1501
Other IDs
2015-005640-34, 2015
Status last verified
Feb 2019
First submitted
28 Oct 2016
Last updated
1 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tacrolimus and Everolimus in people with Kidney Transplantation, run by Chiesi Farmaceutici S.p.A. at 6 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tacrolimus Area Under the curve at 24 hours (AUC24) (time frame: 10 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02970630.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.

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