Organ or Tissue Transplant; ComplicationsPhase 4NCT02500212
Pharmacokinetic Study of ENVARSUS in Adult De-novo Kidney Transplant Patients
A Phase 4 study testing ENVARSUS® and ADVAGRAF® in people with Organ or Tissue Transplant; Complications, run by Chiesi Farmaceutici S.p.A. at 7 sites in France.
Trial summary
Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ or Tissue Transplant; Complications
- What is being tested?
- ENVARSUS® and ADVAGRAF®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 7 sitesFrance
- Study dates
- Jul 2015to Jun 2016
- 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
- Recipients of a kidney transplant from a deceased donor or a living donor
Who cannot join
- Recipient of any transplanted organ other than a kidney;
- 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 incompatible donor;
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Nephrology Department Hopital La Cavale Blanche
Brest, 296009
Clinique de Nephrologie CHU Grenoble
Grenoble, 38043
CHU Limoges
Limoges, 87042
Service de Nephrologie
Montpellier, 34295
Unité de transplantation rénale -Hopital Pasteur
Nice
Nephrology department CHU de Saint-Etienne Hospital Nord
Saint-Etienne, 42055
CHU Rangueil, 1 avenue J Poulhes TSA 50032.
Toulouse, 31400
About this study
Official title: OPEN-LABEL, MULTICENTRE, RANDOMIZED CLINICAL TRIAL TO COMPARE THE PHARMACOKINETICS OF ENVARSUS® TABLETS AND ADVAGRAF® CAPSULES ADMINISTERED ONCE DAILY IN ADULT DE-NOVO KIDNEY TRANSPLANT PATIENTS
Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.
- Being tested
- ENVARSUS®, ADVAGRAF®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENVARSUS®Drug
ADVAGRAF®Drug
| Study group | Role | What they receive |
|---|---|---|
| ENVARSUS tablets | Experimental | Envarsus® (tacrolimus) prolonged-release tablets provided in 0.75 mg, 1.0 mg and 4.0 mg dose strengths.
Envarsus® tablets will be administered orally once daily in the morning Receives: Drug: ENVARSUS® |
| ADVAGRAF capsules | Active comparator | Advagraf® (tacrolimus) prolonged-release hard capsules provided in 0.5 mg, 1.0 mg, 3.0 mg and 5.0 mg dose strengths.
Advagraf® capsules will be administered orally once daily in the morning Receives: Drug: ADVAGRAF® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tacrolimus Area under the curve (AUC 0-24h)r h*pg/mL
Measured: pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hr post-dose
Secondary outcomes (5)
Tacrolimus concentration 24 hours post-dose (C24hr) pg/mL
Whole blood trough drug concentration 24hour post dose
Measured: 24.0 hr post-dose
Serum creatinine (mg/dL)
Measured: before dosing
estimated glomerular filtration rate (eGFR) mL/min;
Measured: before dosing
Heart Rate, (beats per minute)
Measured: before dosing
Qt (milliseconds)
Measured: before dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016
- Study completionJun 2016
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 Organ or Tissue Transplant; ComplicationsStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500212
- Sponsor's protocol ID
- CCD-06235AA1-02
- Other IDs
- 2014-005572-28, 2014
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2015
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Kamar N, Cassuto E, Piotti G, Govoni M, Ciurlia G, Geraci S, Poli G, Nicolini G, Mariat C, Essig M, Malvezzi P, Le Meur Y, Garrigue V, Del Bello A, Rostaing L. Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study. Adv Ther. 2019 Feb;36(2):462-477. doi: 10.1007/s12325-018-0855-1. Epub 2018 Dec 14.
PubMed 30552587
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPEN-LABEL, MULTICENTRE, RANDOMIZED CLINICAL TRIAL TO COMPARE THE PHARMACOKINETICS OF ENVARSUS® TABLETS AND ADVAGRAF® CAPSULES ADMINISTERED ONCE DAILY IN ADULT DE-NOVO KIDNEY TRANSPLANT PATIENTS
- ClinicalTrials.gov ID
- NCT02500212
- Acronym / sponsor ID
- CCD-06235AA1-02
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Jul 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.
Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENVARSUS tablets | Experimental | Drug: ENVARSUS®Envarsus® (tacrolimus) prolonged-release tablets provided in 0.75 mg, 1.0 mg and 4.0 mg dose strengths. Envarsus® tablets will be administered orally once daily in the morning |
| ADVAGRAF capsules | Active comparator | Drug: ADVAGRAF®Advagraf® (tacrolimus) prolonged-release hard capsules provided in 0.5 mg, 1.0 mg, 3.0 mg and 5.0 mg dose strengths. Advagraf® capsules will be administered orally once daily in the morning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recipients of a kidney transplant from a deceased donor or a living donor
Key exclusion criteria (4 listed)
- Recipient of any transplanted organ other than a kidney;
- 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 incompatible donor;
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® | Drug | ENVARSUS tablets |
| ADVAGRAF® | Drug | ADVAGRAF capsules |
Primary outcome
Tacrolimus Area under the curve (AUC 0-24h)r h*pg/mL
Time frame: pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hr post-dose
5 secondary outcomes
Tacrolimus concentration 24 hours post-dose (C24hr) pg/mL
Time frame: 24.0 hr post-dose
Serum creatinine (mg/dL)
Time frame: before dosing
estimated glomerular filtration rate (eGFR) mL/min;
Time frame: before dosing
Heart Rate, (beats per minute)
Time frame: before dosing
Qt (milliseconds)
Time frame: before dosing
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 31 Jul 2020.
- Results publication: PubMed 30552587Kamar N, Cassuto E, Piotti G, Govoni M, Ciurlia G, Geraci S, Poli G, Nicolini G, Mariat C, Essig M, Malvezzi P, Le Meur Y, Garrigue V, Del Bello A, Rostaing L. Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study. Adv Ther. 2019 Feb;36(2):462-477. doi: 10.1007/s12325-018-0855-1. Epub 2018 Dec 14.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites 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® and ADVAGRAF® in people with Organ or Tissue Transplant; Complications, run by Chiesi Farmaceutici S.p.A. at 7 sites in France.
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 1 inclusion and 4 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 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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 Area under the curve (AUC 0-24h)r h*pg/mL (time frame: pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hr post-dose). 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 NCT02500212, 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 31 Jul 2020.