End Stage Renal DiseasePhase 4STEADYNCT02432833
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
A Phase 4 study testing ENVARSUS®, PROGRAF® and ADVAGRAF® in people with End Stage Renal Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- ENVARSUS®, PROGRAF® and ADVAGRAF®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteItaly
- Study dates
- May 2015to 24 Jan 2017
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 20Show fewer
- 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;
- Patient or donor with current diagnosis or history of malignancy within the past 5 years except basal or non-metastatic squamous cell carcinoma of the skin successfully treated;
- Uncontrolled concomitant infection, systemic infection requiring treatment or any other unstable condition that could interfere with study objectives;
- Severe diarrhoea, vomiting, active peptic ulcer or GI disorder that may affect absorption of tacrolimus;
- Known hypersensitivity to tacrolimus other macrolides and study drugs excipients;
- Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are willing to use reliable methods of contraception
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This is a 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. The study will be conducted in approximately 10 european countries.
- Conditions
- End Stage Renal Disease
- Being tested
- ENVARSUS®, PROGRAF®, ADVAGRAF®
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENVARSUS®Drug
Envarsus® tablets, once daily, oral formulation. Prolonged -release formulation of tacrolimus
PROGRAF®Drug
Prograf® hard capsules, twice daily, oral formulation
ADVAGRAF®Drug
Advagraf® prolonged-release hard capsules, once daily, oral formulation
| Study group | Role | What they receive |
|---|---|---|
| Envarsus® (tacrolimus) | Experimental | prolonged-release tablets once daily and orally Receives: Drug: ENVARSUS® |
| Prograf or Advagraf | Active comparator | Prograf® hard capsules, twice daily, oral formulation or Advagraf® prolonged-release hard capsules, once daily, oral formulation Receives: Drug: PROGRAF®; Drug: ADVAGRAF® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tacrolimus total daily dose (TDD) from week 3 to month 6
Measured: from week 3 to month 6
Secondary outcomes (7)
Tacrolimus blood trough level (TL).
Measured: from screening to months 6
number of dose adjustment
Measured: from screening to months 6
Occurrence of treatment failure
Measured: from screening to months 6
Delayed graft function
Measured: from screening to months 6
Acute rejection requiring treatment
Measured: from screening to months 6
Consumption of concomitant immunosuppressant medications
Measured: from screening to months 6
Treatment discontinuation
Measured: from screening to months 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startMay 2015
- Primary completion24 Jan 2017
- Study completion24 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klemens Budde, MD, Principal investigator, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432833
- Sponsor's protocol ID
- CCD-06235AA1-01
- Other IDs
- 2014-004314-29, 2014
- Acronym
- STEADY
- Status last verified
- Apr 2018
- First submitted
- 29 Apr 2015
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36017158
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02432833
- Acronym / sponsor ID
- STEADY / CCD-06235AA1-01
- Conditions
- End Stage Renal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- 24 Jan 2017 (actual)
- Study completion
- 24 Jan 2017 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a 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. The study will be conducted in approximately 10 european countries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Envarsus® (tacrolimus) | Experimental | Drug: ENVARSUS®prolonged-release tablets once daily and orally |
| Prograf or Advagraf | Active comparator | Drug: PROGRAF®, Drug: ADVAGRAF®Prograf® hard capsules, twice daily, oral formulation or Advagraf® prolonged-release hard capsules, once daily, oral formulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENVARSUS®Envarsus® tablets, once daily, oral formulation. Prolonged -release formulation of tacrolimus | Drug | Envarsus® (tacrolimus) |
| PROGRAF®Prograf® hard capsules, twice daily, oral formulation | Drug | Prograf or Advagraf |
| ADVAGRAF®Advagraf® prolonged-release hard capsules, once daily, oral formulation | Drug | Prograf or Advagraf |
Primary outcome
Tacrolimus total daily dose (TDD) from week 3 to month 6
Time frame: from week 3 to month 6
7 secondary outcomes
Tacrolimus blood trough level (TL).
Time frame: from screening to months 6
number of dose adjustment
Time frame: from screening to months 6
Occurrence of treatment failure
Time frame: from screening to months 6
Delayed graft function
Time frame: from screening to months 6
Acute rejection requiring treatment
Time frame: from screening to months 6
Consumption of concomitant immunosuppressant medications
Time frame: from screening to months 6
Treatment discontinuation
Time frame: from screening to months 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Derived from this study: PubMed 36017158Budde 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.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for End Stage Renal Disease
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klemens Budde, MD principal investigator
Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ENVARSUS®, PROGRAF® and ADVAGRAF® in people with End Stage Renal Disease, run by Chiesi Farmaceutici S.p.A. at 1 site 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 6 inclusion and 20 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 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 total daily dose (TDD) from week 3 to month 6 (time frame: from week 3 to month 6). 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 NCT02432833, which also lists 1 linked publication.
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 13 Apr 2018.