A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus. (ADHERE)

October 29, 2024 updated by: Astellas Pharma Inc

A Multicenter, Two Arm, Randomized, Open Label Clinical Study Investigating Renal Function in an Advagraf® Based Immunosuppressive Regimen With or Without Sirolimus in Kidney Transplant Patients

The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will evaluate the potential to reduce nephrotoxic calcineurin inhibitors (CNI) therapy by lowering tacrolimus exposure from Advagraf® in combination with the non-nephrotoxic immunosuppressant sirolimus to avoid the risk of acute graft rejection, compared with an Advagraf® and Mycophenolate Mofetil (MMF) immunosuppressive regimen.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
853

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • New Lambton, Australia, NSW 2305
        • 5042
      • Perth, Australia, WA 6009
        • 5043
  • Austria
      • Innsbruck, Austria, 6020
        • 1141
      • Linz, Austria, 4020
        • 1142
      • Vienna, Austria, 1090
        • 1140
  • Belarus
      • Minsk, Belarus, 220116
        • 3240
  • Belgium
      • Leuven, Belgium, 3000
        • 1241
      • Liege 1, Belgium, 4000
        • 1240
  • Czechia
      • Brno, Czechia, 656 91
        • Site 1441
      • Ostrava - Poruba, Czechia, 78 52
        • 1440
  • France
      • Amiens Cedex, France, 80054
        • 1752
      • Brest Cedex 2, France, 29609
        • 1740
      • Clermont-Ferrand Cedex 1, France, 63003
        • 1742
      • Creteil Cedex, France, 94010
        • 1746
      • Dijon, France, 21000
        • 1750
      • Le Kremilin Bicetre Cedex, France, 94275
        • 1741
      • Paris Cedex 15, France, 75743
        • 1749
      • Toulouse Cedex 9, France, 31059
        • 1751
      • Tours cedex 9, France, 37044
        • 1748
      • Vandoeuvre Les Nancy Cedex, France, 54511
        • 1745
  • Germany
      • Bochum, Germany, 44892
        • 1541
      • Erlangen, Germany, 91054
        • 1542
      • Essen, Germany, 45147
        • 1543
      • Frankfurt, Germany, 60596
        • 1544
      • Hann.Munden, Germany, 34346
        • 1545
      • Hannover, Germany, 30625
        • 1540
      • Heidelberg, Germany, 69120
        • 1546
      • Kiel, Germany, 24105
        • 1547
      • Leipzig, Germany, 04103
        • 1548
      • Munchen, Germany, 81377
        • 1549
      • Munster, Germany, 48149
        • 1550
  • Hong Kong
      • Hong Kong, Hong Kong
        • 5441
  • Hungary
      • Budapest, Hungary, 1082
        • 1940
  • Italy
      • Palermo, Italy, 90124
        • 2144
      • Roma, Italy, 00168
        • 2143
      • Siena, Italy, 53100
        • 2140
  • Korea, Republic of
      • Busan, Korea, Republic of, 614-735
        • 5245
      • Daegu, Korea, Republic of, 700-721
        • 5243
      • Seoul, Korea, Republic of, 110-744
        • 5242
      • Seoul, Korea, Republic of, 120-752
        • 5241
      • Seoul, Korea, Republic of, 138-736
        • 5244
  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • 2440
  • Poland
      • Katowice, Poland, 40-027
        • 2643
      • Lodz, Poland, 91-153
        • 2640
      • Poznan, Poland, 60-479
        • 2641
  • Russian Federation
      • Kemerovo, Russian Federation, 650066
        • 2841
      • Moscow, Russian Federation, 115446
        • 2843
      • Omsk, Russian Federation, 644112
        • 2842
      • Vol'ginskiy, Russian Federation, 404120
        • 2840
  • Spain
      • Alicante, Spain, 03010
        • 1640
      • Barcelona, Spain, 08907
        • 1641
      • Santander, Spain, 39008
        • 1643
      • Vizcaya, Spain, 48903
        • 1642
  • Taiwan
      • Tainan, Taiwan, 70403
        • 5343
      • Taoyuan, Taiwan, 33305
        • 5342
  • Turkey
      • Istanbul, Turkey, 07058
        • 3042
      • Istanbul, Turkey, 34245
        • 3043
      • Istanbul, Turkey, 34732
        • 3044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 6 months)
  • Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen [HLA] identical) donor with compatible ABO blood type
  • Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment
  • Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ ICH/ 286/ 95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner

Exclusion Criteria:

  • Receiving or having previously received an organ transplant other than a kidney
  • Cold ischemia time of the donor kidney > 30 hours
  • Panel Reactive Antibody (PRA) >20%
  • Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest)
  • Significant liver disease, defined as having continuously elevated SGPT/ ALT and/ or SGOT/ AST and/ or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
  • Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
  • Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (other than minimal levels of immunosuppression following failure of previous transplantation without nephrectomy)
  • Significant, uncontrolled concomitant infections and/ or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
  • Pregnant woman or breast-feeding mother
  • Subject or donor known to be HIV positive
  • Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, sirolimus, MMF or any of the product excipients or iodine
  • Evidence of malignant disease within the last 5 years, not including non-malignant skin cancers
  • Currently participating in another clinical trial, and/ or has taken an investigational drug within 28 days prior to enrollment
  • Unlikely to comply with the visits scheduled in the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Advagraf + MMF + Steroids
Without sirolimus
Drug: Mycophenolate Mofetil
oral
Other Names:
  • CellCept
Drug: Advagraf
oral
Other Names:
  • FK506E
  • Prolonged release tacrolimus
Drug: Corticosteroids
i.v. and oral
Experimental: Advagraf + MMF + Steroids + Sirolimus
With sirolimus; MMF withdrawn on Day 28; Sirolimus introduced on Day 28
Drug: Mycophenolate Mofetil
oral
Other Names:
  • CellCept
Drug: Advagraf
oral
Other Names:
  • FK506E
  • Prolonged release tacrolimus
Drug: Corticosteroids
i.v. and oral
Drug: Sirolimus
oral
Other Names:
  • Rapamune

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Glomerular Filtration Rate (GFR) estimated by iohexol clearance at Week 52 post kidney transplantation
Time Frame: up to 1 year
up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy failure
Time Frame: up to 1 year
Composite endpoint defined as graft loss (re-transplantation, nephrectomy, death or dialysis ongoing at the study end) or subject withdrawal
up to 1 year
GFR at Week 52 post kidney transplantation by Modification Diet in Renal Disease (MDRD) formula
Time Frame: up to 1 year
up to 1 year
GFR at Week 52 post kidney transplantation by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
Time Frame: up to 1 year
up to 1 year
Calculated creatinine clearance at Week 52 post kidney transplantation by Cockcroft and Gault formula
Time Frame: up to 1 year
up to 1 year
Incidence of clinical acute rejection
Time Frame: up to 1 year
up to 1 year
Time to clinical acute rejection
Time Frame: up to 1 year
up to 1 year
Incidence of Biopsy Confirmed Acute Rejection
Time Frame: up to 1 year
up to 1 year
Time to Biopsy Confirmed Acute Rejection
Time Frame: up to 1 year
up to 1 year
Subject survival
Time Frame: up to 1 year
up to 1 year
Graft survival
Time Frame: up to 1 year
up to 1 year
New Onset Diabetes Mellitus (NODM) as per American Diabetic Association (ADA) criteria
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Use Central Contact, Astellas Pharma Europe Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 18, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 18, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PMR-EC-1212
  • 2010-019639-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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