Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study (CD4-01)

October 12, 2016 updated by: University Hospital, Ghent
This study is an open, randomised trial in which one group of patients (control) will receive the golden standard therapy and the other group (treatment) will receive individually adapted immunosuppression.

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.

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.
128

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

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First or second kidney transplantation
  • Males and females, 18 years old or older
  • Women of childbearing potential must have a negative serum or urine pregnancy test with sensitivity equal to at least 50 mIU/mL
  • Patients must be capable of understanding the purpose and risks of the study and must sign an informed consent form

Exclusion Criteria:

  • Multiple organ transplantation (eg. kidney-pancreas, kidney-heart, kidney-liver,...)
  • Transplantation of a patient who received another organ transplant previously except one kidney transplant
  • Recipients of HLA-identical living-related renal transplants
  • Patients with PRA > 10%, patients who have lost a first graft from rejection.
  • Pregnant or lactating women
  • WBC =< 2.5 x 109/L (IU), platelet count =< 100 x 109/L (IU), or Hb =< 6g/dl at the time of entry into the study
  • Active peptic ulcer
  • Severe diarrhea or other gastrointestinal disorders which might interfere with the ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy
  • Known HIV-1 or HTLV-1 positive tests
  • History of malignancy in the past 5 years (with the exception of adequately treated basal or squamous skin cell carcinoma)
  • The use of investigational drugs or other immunosuppressive drugs as those specified in this protocol
  • Patients receiving bile acid sequestrants
  • Psychological illness or condition interfering with the patient's compliance or ability to understand the requirements of the study.

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: Treatment
  • 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.
Experimental: 1
individual adapted immunosuppression
Drug: individual adapted immunosuppression
individual adapted immunosuppression
Active Comparator: 2
golden standard therapy
Drug: golden standard therapy
golden standard therapy

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
Graft function as measured by Cr EDTA AUC
Time Frame: at 1 year
at 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
Time Frame
Graft survival
Time Frame: at 1 year
at 1 year
Patient survival
Time Frame: at 1 year
at 1 year
Graft function measured by estimated GFR (eGFR) (MDRD and Cockroft-Gault)
Time Frame: at 1 year
at 1 year
Frequency of biopsy proven acute rejection episodes
Time Frame: at 1 year
at 1 year
Incidence of biopsy proven acute rejection (BPAR) and clinical (non-biopsy proven) acute rejection episodes treated by a full course anti-rejection therapy (e.g. steroids) (Treatment of rejection according to center practice).
Time Frame: at 1 year
at 1 year
Incidence of rejection treated by antibodies (OKT3, ATG)
Time Frame: at 1 year
at 1 year
Time to first rejection (days)
Time Frame: at 1 year
at 1 year
Severity of rejection as assessed by BANFF 2005 score
Time Frame: at 1 year
at 1 year
Number of acute rejections per patient
Time Frame: at 1 year
at 1 year
Plasma creatinine and eGFR
Time Frame: at month 1, 3 and yearly (2 and 3 years)
at month 1, 3 and yearly (2 and 3 years)
Measured GFR
Time Frame: at month 3 and yearly
at month 3 and yearly
Proteinuria
Time Frame: at month 1, 3 and at 1 and 3 years
at month 1, 3 and at 1 and 3 years
Incidence and score of borderline changes and acute rejection
Time Frame: in month 3 and month 12 biopsy
in month 3 and month 12 biopsy
Incidence and score of chronic alloimmune injury/rejection and nonimmune injury
Time Frame: in month 3 and month 12 biopsies (BANFF 2005)
in month 3 and month 12 biopsies (BANFF 2005)
Development and evolution of glucose abnormalities
Time Frame: at 1 year
at 1 year
blood pressure
Time Frame: at 1 year
at 1 year
ambulatory 24-hr blood pressure monitoring
Time Frame: at 1 year and 3 years
at 1 year and 3 years
Left ventricular mass assessed by echocardiography
Time Frame: at 1 year and 3 years
at 1 year and 3 years
Fasting lipid profile
Time Frame: at baseline, month 1,3,6 and yearly
at baseline, month 1,3,6 and yearly
CMV infection (as measured with whole blood PCR) and disease
Time Frame: at 1 year
at 1 year
Polyoma virus replication as measured by whole blood PCR
Time Frame: at 1 year
at 1 year
Incidence of BK nephritis
Time Frame: in month 3 and month 12 biopsies
in month 3 and month 12 biopsies
Incidence of PTLD and Nonmelanoma skin cancer
Time Frame: at 1 year and yearly
at 1 year and yearly
Incidence of EBV reactivation (as measured with whole blood PCR)
Time Frame: at 1 year and yearly
at 1 year and yearly

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.
University Hospital, Ghent

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Pharma AG

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.
  • Principal Investigator: Raymond Vanholder, MD, PhD, University Hospital, Ghent

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

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.
May 1, 2009

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.
August 1, 2016

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.
October 1, 2016

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 7, 2009

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 7, 2009

First Posted (Estimate)

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.
May 8, 2009

Study Record Updates

Last Update Posted (Estimate)

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 13, 2016

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 12, 2016

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, 2016

More Information

Terms related to this study

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.
  • 2008/640

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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