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De Novo Transplant DiseasePhase 4ADEQUATENCT01744470

Efficacy and Safety Study of a 4-Month Post-Renal Transplant Dose Reduction of Tacrolimus(ADEQUATE)

A Phase 4 study testing Tacrolimus targeted half-dose and Tacrolimus targeted plain dose in people with De Novo Transplant Disease, run by University Hospital, Tours at 16 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This prospective, interventional, open label, randomized, multicenter study was designed to determine the risk/benefit ratio of a 50 % reduction of Advagraf® daily dose, 4 months after transplantation. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
De Novo Transplant Disease
What is being tested?
Tacrolimus targeted half-dose and Tacrolimus targeted plain dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
286 participants
Where
16 sitesFrance
Study dates
May 2012to Mar 2015
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 et 70 years
  • Patient accepting to give a written informed consent
  • Recipients of a first renal allograft
  • Cadaver or living transplantation or living (non HLA identical) donor with compatible ABO blood type.
  • Absence of positive DSA using Luminex®, MFI>1,000
  • Negative cross-match in cytotoxicity
  • Patient without difficulty to understand and communicate with the investigator and his collaborators
  • Patient entitled to Health System benefits or other such benefits.

Who cannot join

  • Multiple organ transplantation
  • Recipients of a dual kidney transplant
  • Previous renal allograft
  • History of any other transplantation
  • Receiving a graft from a non-heart-beating donor
  • Patient BMI > 35
Show all 15Show fewer
  • Patients with evidence of severe liver disease, including abnormal liver profile (AST, ALT, or total bilirubin > 3 times upper limit of normal) at screening.
  • Significant severe infection, active peptic ulcer and/or difficulty to absorb oral drugs (active upper gastro-intestinal tract malabsorption syndrome)
  • HIV-positive patients, or with an active B or C hepatitis
  • Patients with de novo malignancy prior to transplantation, other than efficiently treated basal or squamous cell carcinoma of the skin.
  • Leucocyte count lower than 2500/mm3
  • Female patients who are pregnant, lactating or of child bearing potential and not practicing an approved method of birth control.
  • Known allergy or intolerance to basiliximab, tacrolimus, macrolide antibiotics, corticosteroids, or mycophenolate mofetil or any of the product excipients
  • Participation in a clinical trial or expanded access trial with an investigational drug within 4 weeks prior to enrollment or concomitantly with this study
  • Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • Hôpital Sud

    Amiens

  • CHU de Angers

    Angers

  • Hôpital Bois-Guillaume

    Bois-Guillaume, 76130

  • Hôpital Cavale Blanche

    Brest

  • CHU de Caen

    Caen

  • Hôpital Gabriel Montpied

    Clermont-Ferrand

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre

  • Hôpital Dupuytren

    Limoges

  • Hôpital Archet II

    Nice

  • HEGP

    Paris, 75015

  • Hôpital Necker

    Paris

  • Hôpital Maison Blanche

    Reims

  • Hôpital Pontchaillou

    Rennes

  • Hôpital Civil

    Strasbourg

  • CHU de Toulouse

    Toulouse

  • CHRU de Tours

    Tours

Other trials in France

About this study

Official title: Efficacy and Safety Outcome of Two Different Targets of Advagraf® Trough Levels Between 4 Months and 12 Months After Transplantation Among de Novo Renal Transplant Recipients.

This prospective, interventional, open label, randomized, multicenter study was designed to determine the risk/benefit ratio of a 50 % reduction of Advagraf® daily dose, 4 months after transplantation. Randomized patients are to be stable with their tacrolimus daily dose required to reach targeted tacrolimus trough levels. Based on Month-3 eligibility assessments, patients will be randomized in two groups (1:1): patients with 50 % reduction of the daily dose of Advagraf® 4 months after transplantation, and patients kept on their usual dose. The benefit/risk ratio will include the assessment of renal function, histological lesions from both alloreactivity and CNI nephrotoxicity, and safety data (metabolic and infectious diseases).

Being tested
Tacrolimus targeted half-dose, Tacrolimus targeted plain dose
Keywords
Renal, Transplantation, Tacrolimus

What participants receive

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

  • Tacrolimus targeted half-doseDrug

    Also called Advagraf®

  • Tacrolimus targeted plain doseDrug

    Also called Advagraf®

Study groups in NCT01744470
Study groupRoleWhat they receive
Group A - tacrolimus half-doseExperimentalImmunosuppressive strategy with 50 % reduction of Advagraf® daily dose at M4 (randomization) and unchanged MMF dose. Targeted tacrolimus trough level are to be higher than 3 ng/mL . If the dose is not in adequation with the dispensable units, the prescribed dose will be the closest higher dose. Drug: Tacrolimus targeted half-dose
Receives: Drug: Tacrolimus targeted half-dose
Group B - tacrolimus unchanged doseExperimentalImmunosuppressive strategy will remain identical after randomization (M4): unchanged Advagraf® and MMF doses. Targeted tacrolimus trough level are to be between 7 and 12 ng/mL Drug: Tacrolimus targeted plain dose
Receives: Drug: Tacrolimus targeted plain dose

What is being measured

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

  1. Renal function at one year post transplantation

    Renal function at one year post transplantation estimated by the glomerular filtration rate (GFR) using MDRD 4 (Modification Diet in Renal Disease). Crude difference in renal function at one year between groups and the change of renal function between 4 months and one year in each group will be analyzed and compared.

    Measured: 12 months

Secondary outcomes (7)

  1. To determine and compare according to randomized group

    Routine graft histology at M12 assessed using Banff 2009 classification, with specific analysis of interstitial fibrosis (IF) using numeric quantification

    Measured: 12 months

  2. To determine and compare according to randomized group

    Glucose metabolism at M4 and M12

    Measured: 12 months

  3. To determine and compare according to randomized group

    Infection rate including BKV and CMV at M4 and M12

    Measured: 12 months

  4. To determine and compare according to randomized group

    Presence and intensity of Donor Specific Antibody (DSA) at M3 and M12

    Measured: 12 months

  5. To determine and compare according to randomized group

    Incidence of biopsy proven acute rejection episode at M12

    Measured: 12 months

  6. To determine and compare according to randomized group

    Graft and patient survival at M12

    Measured: 12 months

  7. To determine and compare according to randomized group

    Overall safety assessment

    Measured: 12 months

Timeline

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

  1. First posted6 Dec 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionMar 2015 (estimated)
  4. Study completionMar 2015 (estimated)

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
286 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01744470
Sponsor's protocol ID
PHAO2011/YL/ADEQUATE
Other IDs
2011-003184-29
Acronym
ADEQUATE
Status last verified
Apr 2014
First submitted
11 Jun 2012
Last updated
8 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Gatault P, Kamar N, Buchler M, Colosio C, Bertrand D, Durrbach A, Albano L, Rivalan J, Le Meur Y, Essig M, Bouvier N, Legendre C, Moulin B, Heng AE, Weestel PF, Sayegh J, Charpentier B, Rostaing L, Thervet E, Lebranchu Y. Reduction of Extended-Release Tacrolimus Dose in Low-Immunological-Risk Kidney Transplant Recipients Increases Risk of Rejection and Appearance of Donor-Specific Antibodies: A Randomized Study. Am J Transplant. 2017 May;17(5):1370-1379. doi: 10.1111/ajt.14109. Epub 2017 Jan 3.

    PubMed 27862923

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tacrolimus targeted half-dose and Tacrolimus targeted plain dose in people with De Novo Transplant Disease, run by University Hospital, Tours at 16 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 8 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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?

Results are not available in the source record.

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?

Renal function at one year post transplantation (time frame: 12 months). 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 NCT01744470, 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 8 Apr 2014.

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