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Function of Renal TransplantPhase 3NCT01292525

Protocol Calcineurin Inhibitor (CNI) Weaning

A Phase 3 study testing Tacrolimus in people with Function of Renal Transplant, run by Nantes University Hospital at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The main objective of this study is to demonstrate the benefit of the withdrawal of Tacrolimus (Prograf®) on renal function in patients one year after the end of the weaning period. The secondary objectives will focus on assessing the risks and consequences of withdrawal of Tacrolimus (Prograf®). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Function of Renal Transplant
What is being tested?
Tacrolimus
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteFrance
Study dates
May 2011to May 2015
Phase
Phase 3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Glomerular Filtration Rate (GFR), defined by the dosage of cystatin C ≥ 40 ml/min/1, 73m²,
  • Proteinuria ≤ 0,5 g / day,
  • Patient with serum levels of Tacrolimus between 5 to 10 ng / ml on average during the last 6 months (inclusive). It is accepted that 25% of the assays performed during the last 6 months, serum levels of tacrolimus are outside the limits mentioned above (5-10 ng / ml). They must nevertheless be between 3.5 to 12.5 ng / ml (inclusive).
  • Patient with serum levels of MPA (Cellcept® and Myfortic®) higher ≥ 30 mg / ml,
  • No anti-HLA antibodies at the time of inclusion, verified using highly sensitive techniques (Luminex HD),
  • Lack of histological evidence of cellular or humoral acute or chronic or subclinical rejection on renal graft according to the latest classification of Banff 2009.

Who cannot join

  • Patients under age 18 or over 80 years,
  • Transplanted from less than 4 years and over 10 years,
  • Patients re-transplanted,
  • Transplantation of several organs,
  • Patient not treated with tacrolimus as maintenance therapy,
  • Serum levels of Tacrolimus patient <5 or >10 ng / ml,
Show all 20Show fewer
  • Serum levels of MPA of the patient <30 mg / ml,
  • Patients treated with other immunosuppressive drugs that Tacrolimus (Prograf®), MPA (Cellcept® and Myfortic®) and steroids,
  • Patient not having a stable graft function at baseline (change in serum creatinine > 25% of the average of the year before inclusion in the study), with a GFR defined by the dosage of cystatin C <40 ml/min/1, 73m² at the time of inclusion,- Patients with proteinuria > 0.5 g at study entry,
  • Patient with HLA antibodies at study entry,
  • Patient non-compliant,
  • Presence of histological evidence of cellular or humoral acute or chronic or subclinical rejection on renal graft according to the latest classification of Banff 2009,
  • History of lymphoproliferative disorders,
  • Diagnosis of a malignancy within 5 years before enrollment,
  • Significantly abnormal hematologic data of a clinical standpoint, as determined by the investigator for hematocrit, hemoglobin, white blood cell count or platelets,
  • Data significantly abnormal blood biochemistry of a clinical standpoint, as determined by the investigator,
  • Abuse of significant drug or alcohol at the time of inclusion, determined by the investigator,
  • Patient positive for antibodies to hepatitis C or hepatitis B surface antigen of hepatitis B (HBsAg) or HIV infection,
  • Participation in a clinical study within 3 months,
  • Pregnancy, Breastfeeding.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Nantes University Hospital

    Nantes, 44093

Other trials in France

About this study

Official title: Prospective, Multicenter, Randomized, Double-blind, Controlled Parallel Group Study Designed to Assess the Risk-benefit Balance of the Gradual Withdrawal of a Calcineurin Inhibitor (Tacrolimus) in Renal Transplant Patients Over 4 Years and Clinically Selected

The main objective of this study is to demonstrate the benefit of the withdrawal of Tacrolimus (Prograf®) on renal function in patients one year after the end of the weaning period. The secondary objectives will focus on assessing the risks and consequences of withdrawal of Tacrolimus (Prograf®).

Being tested
Tacrolimus, Placebo
Keywords
Withdrawal of Tacrolimus and renal graft, renal allograft, stable renal function

What participants receive

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

  • TacrolimusDrug

    A control group continued conventional therapy, Tacrolimus (Prograf®) ("control" group) and will be followed in parallel group "withdrawal" that will stop treatment with Tacrolimus (Prograf®).

  • PlaceboDrug

    Patients randomized to the "withdrawal"group will begin the protocol with their usual dose of Tacrolimus (Prograf®) (initial dose). The initial dose of tacrolimus (Prograf®) will be reduced by one third at visit 3 (day 0) and again a third visit 5 (J60). The complete withdrawal Tacrolimus (Prograf®) begins to visit 7 (J120). The withdrawal of Tacrolimus (Prograf®) will be obtained in four months. Monitoring of all patients lasted 17 months in total from the screening visit, which corresponds to 12 months after complete withdrawal of Tacrolimus (Prograf®) for patients in the "withdrawal" group.

Study groups in NCT01292525
Study groupRoleWhat they receive
TacrolimusActive comparatorNot described
Receives: Drug: Tacrolimus
Withdrawal of TacrolimusExperimentalNot described
Receives: Drug: Placebo

What is being measured

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

  1. Renal function

    The primary endpoint will be the improvement of renal function one year after complete withdrawal of Tacrolimus (Prograf®) assessed by measuring the glomerular filtration rate (GFR) calculated by the dosage of cystatin C according to the equation Bricon. The DFG will be compared between times J-30 and J480 (1 year after the withdrawal).

    Measured: one year after complete withdrawal of Tacrolimus

Secondary outcomes (12)

  1. Renal function

    Improvement of renal function by measuring serum creatinine, using the original MDRD equation,

    Measured: one year after complete withdrawal

  2. Acute rejection

    Rate of histologically proven acute rejection by biopsy according to Banff classification 2009,

    Measured: one year after complete withdrawal

  3. Chronic rejection

    Rate of chronic rejection histologically proven by biopsy according to Banff classification 2009,

    Measured: One year after complete withdrawal

  4. Steroid-resistant rejection

    Rates of steroid-resistant rejection

    Measured: One year after complete withdrawal

  5. Graft survival

    Rate of return to dialysis (graft survival)

    Measured: One year after complete withdrawal

  6. Cancer and infections

    Incidence of cancer and infections

    Measured: one year after complete withdrawal

  7. Patients survival

    Survival rate of patients

    Measured: One year after complete withdrawal

  8. Anti-HLA antibodies

    Appearance of anti-HLA donor specific and non-donor specific antibodies measured by the technique Luminex

    Measured: One year after complete withdrawal

  9. Histological lesions of rejection

    The appearance of histological lesions of cellular or humoral acute or chronic or subclinical rejection on the biopsy protocol

    Measured: One year after complete withdrawal

  10. Histological lesions of fibrosis

    Onset or worsening of histological lesions of interstitial fibrosis and tubular atrophy on biopsy inflammatory

    Measured: One year after complete withdrawal

  11. Hypertension, hyperglycemia and hyperlipidemia

    Incidence of hypertension, hyperglycemia and hyperlipidemia

    Measured: One year after complete withdrawal

  12. Quality of life

    Determination of the benefits of withdrawal of Tacrolimus on the quality of life of patients, defined by the scale of quality of life validated SF-36 used at the beginning (J-15) and at the end of the weaning period (J120) at 6 months (J300) and one year after complete withdrawal of Tacrolimus (J480)

    Measured: One year after complete withdrawal

Timeline

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

  1. First posted9 Feb 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionMay 2015
  4. Study completionMay 2015

Why it stopped: Difficulties of recruitment

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01292525
Sponsor's protocol ID
09/7-D
Other IDs
2010-019574-33
Status last verified
May 2015
First submitted
8 Feb 2011
Last updated
23 Mar 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Masset C, Dantal J, Soulillou JP, Walencik A, Delbos F, Brouard S, Giral M; Nantes DIVAT Consortium. Case Report: Long-term observations from the tacrolimus weaning randomized clinical trial depicts the challenging aspects for determination of low-immunological risk patients. Front Immunol. 2022 Nov 28;13:1021481. doi: 10.3389/fimmu.2022.1021481. eCollection 2022.

    PubMed 36518770

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tacrolimus in people with Function of Renal Transplant, run by Nantes University Hospital at 1 site 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 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: stopped early, as of the sponsor's last update on 23 Mar 2016. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: Difficulties of recruitment). 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 (time frame: one year after complete withdrawal of Tacrolimus). 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 NCT01292525, 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 23 Mar 2016.

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