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Renal TransplantPhase 4AstronefNCT01541176

Absence of Steroid in Renal Transplantation and Digital Fibrosis Observation

A Phase 4 study testing Absence of corticotherapy post-transplantation and Corticotherapy post-transplantation in people with Renal Transplant, run by Nantes University Hospital at 8 sites in France.

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

The main objective of this study is to demonstrate that the absence of post-transplantation corticosteroids does not induce a larger increase of renal graft fibrosis (by numerical reading) on biopsy at one year post-transplantation than immunosuppressive treatment strategy that includes standard oral… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Renal Transplant
What is being tested?
Absence of corticotherapy post-transplantation and Corticotherapy post-transplantation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
193 participants
Where
8 sitesFrance
Study dates
Apr 2012to Aug 2018
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

  • Transplant of a kidney from a deceased or living donor (non HLA-identical) with ABO compatibility,
  • Existence of a renal graft biopsy (or of one of the grafts, if bi-renal transplant) before transplantation,
  • Percentage of positive responses to PRA (panel reactive antibodies), measured by the Luminex® less than 20% of IgG anti-T or absence of positive DSA by Luminex regardless of the mean fluorescence (MFI) within the last 6 months,
  • Negative cross match T in cytotoxicity and / or flow cytometry,
  • Negative pregnancy test for patients of childbearing age, and consent to use an effective contraception throughout the study and 6 weeks after the end of the study.

Who cannot join

  • First renal transplant lost due to rejection,
  • Combined transplantation,
  • Previous history of transplantation other than kidney,
  • Non beating donor heart,
  • Presence of positive DSA by Luminex® regardless of the average of fluorescence (MFI),
  • Patients receiving corticosteroids at the time of transplantation,
Show all 16Show fewer
  • Necessity to continue administration of systemic immunosuppressive treatment before transplantation,
  • Infections or severe diarrhea, vomiting, upper gastrointestinal tract malabsorption or active peptic ulcers, concomitant, significant and uncontrolled,
  • Subject or HIV positive donor,
  • Replicating viral hepatitis at the time of randomization,
  • Known allergy or intolerance to tacrolimus, macrolide, corticosteroids, mycophenolate mofetil or to any of the excipients,
  • Diagnosis of de novo malignancy prior to transplantation, with the exception of treated effectively basal cell or squamous cell carcinomas of the skin,- Current participation at another clinical study,
  • All clinical condition that the investigator considers incompatible with the conduct of the study in acceptable security conditions,
  • Inability of patient to comply with study procedures,
  • Pregnant or breast-feeding women,
  • Person placed under guardianship, under protection of law.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • CHU de Lyon

    Lyon, 69437

  • Nantes University Hospital

    Nantes, 44093

  • CHU de Nice

    Nice, 06000

  • AP-HP - Hôpital Necker

    Paris, 75743

  • AP-HP - Hôpital Bicêtre

    Paris, 94275

  • CHU de Saint-Etienne

    Saint-Etienne, 42270

  • CHU de Toulouse

    Toulouse, 31049

  • CHRU de Tours

    Tours, 37044

Other trials in France

About this study

Official title: Impact of the Absence of Steroids on the Evolution of Renal Function and on the Progression of Graft Fibrosis, Quantified by Numerical Method, in Patients With Renal Transplant

The main objective of this study is to demonstrate that the absence of post-transplantation corticosteroids does not induce a larger increase of renal graft fibrosis (by numerical reading) on biopsy at one year post-transplantation than immunosuppressive treatment strategy that includes standard oral corticosteroids.The secondary objectives of the study consist to compare on various parameters (fibrosis progression, renal function, dialysis, ratio of proteinuria/creatinuria, acute rejection, donor-specific antibody, graft survival, clinical and biological tolerance) therapy with no corticosteroids post-transplantation in comparison to standard immunosuppressive treatment strategies including oral corticosteroids. Secondary objectives of the study consist also to compare the two techniques for assessing fibrosis by numerical reading and by centralized blinded reading of the treatment group (by 2 anatomical pathologists).

Being tested
Absence of corticotherapy post-transplantation, Corticotherapy post-transplantation
Keywords
Corticotherapy, Fibrosis, Numerical reading, 18-70 years, first renal transplant was lost due to rejection, first or second renal transplant
Medical subject headings
Fibrosis

What participants receive

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

  • Absence of corticotherapy post-transplantationOther

    No study treatment

  • Corticotherapy post-transplantationDrug

    Prednisone or prednisolone orally for at least one year post-transplantation with the following minimal doses :

    • D1 to D14 : 20 mg/day,
    • D15 to M1 : 15 mg/day,
    • M1 to M3 : 10 mg/day,
    • M3 to M12 : 5 mg/day.
Study groups in NCT01541176
Study groupRoleWhat they receive
Absence of corticotherapy post-transplantationExperimentalAll patients included in this arm will receive the usual treatment strategy (including Advagraf, Cellcept ou Myfortic and Simulect) without corticotherapy post-transplantation.
Receives: Other: Absence of corticotherapy post-transplantation
Corticotherapy post-transplantationActive comparatorAll patients included in this arm will receive the usual treatment strategy (including Advagraf, Cellcept ou Myfortic and Simulect) with corticotherapy post-transplantation : prednisone or prednisolone orally for at least one year post-transplantation.
Receives: Drug: Corticotherapy post-transplantation

What is being measured

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

  1. Percentage of fibrosis of the graft

    Evolution of the percentage of fibrosis of the graft during the first year after transplantation (pre-transplant biopsy versus biopsy at one year), by numerical reading of fibrosis by image analysis.

    Measured: One year post-transplantation

Secondary outcomes (10)

  1. Percentage of fibrosis of the graft

    Evolution of the percentage of fibrosis of the graft during the first year after transplantation (pre-transplant biopsy versus biopsy at one year of which the blinded readings to treatment group are made by two independent anatomical pathologists, the Banff criteria 2009).

    Measured: One year post-transplantation

  2. Percentage of fibrosis of the graft.

    The percentage of fibrosis of the graft at one year post-transplantation (biopsy at one year with numerical reading of fibrosis by image analysis and blinded reading to treatment group by two independent anatomical pathologists, the Banff criteria 2009).

    Measured: One year post-transplantation

  3. Average glomerular filtration rate

    The average glomerular filtration rate, calculated by the MDRD formula (four variables, Modification Diet in Renal Disease).

    Measured: One year post-transplantation

  4. Dialysis session

    The percentage of patients with at least one dialysis session realised during the first year of transplant.

    Measured: One year post-transplantation

  5. Ratio of proteinuria/creatinuria

    Average of ratio of proteinuria/creatininuria (mg / mmol).

    Measured: One year post-transplantation

  6. Episode of acute rejection

    The percentage of patients with at least one episode of acute rejection during the first year after transplantation. We will distinguish biopsy-proven acute rejection (RABP), the corticosteroids resistant RABP and severe RABP (Banff 2009).

    Measured: One year post-transplantation

  7. Diagnosis of DSA

    The percentage of patients with a diagnosis of DSA (Luminex® method) at 3 months and 1 year post-transplantation.

    Measured: One year post-transplantation

  8. Percentage of graft failure

    The percentage of graft failure (death or return to dialysis) during the first year of transplantation (the short duration of the study avoids the management of right censoring).

    Measured: One year post-transplantation

  9. Difference between numerical reading of fibrosis and evaluation by anatomical pathologists

    The difference between the percentage of graft fibrosis evaluated by numerical reading of fibrosis and that assessed by two independent anatomical pathologists (Banff 2009 criteria) at baseline, 3 months and 1 year post-transplantation.

    Measured: One year post-transplantation

  10. Number of adverse events

    Adverse events (AE) at 12 months post-transplantation, of which AEs of special interest (NODAT, dyslipidemia, hypertension, CMV viral infections, BKV) with an assessment of vital signs, physical examinations and laboratory tests.

    Measured: One year post-transplantation

Timeline

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

  1. First posted29 Feb 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionAug 2018
  4. Study completionAug 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01541176
Sponsor's protocol ID
RC11_0013
Acronym
Astronef
Status last verified
Jan 2019
First submitted
23 Feb 2012
Last updated
31 Jan 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Absence of corticotherapy post-transplantation and Corticotherapy post-transplantation in people with Renal Transplant, run by Nantes University Hospital at 8 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 5 inclusion and 16 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 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

Percentage of fibrosis of the graft (time frame: One year post-transplantation). 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 NCT01541176.

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 Jan 2019.

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