Kidney TransplantationPhase 4CD4-01NCT00895206
Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study
A Phase 4 study testing individual adapted immunosuppression and golden standard therapy in people with Kidney Transplantation, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- individual adapted immunosuppression and golden standard therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteBelgium
- Study dates
- May 2009to Oct 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Kidney Transplantation
- Being tested
- individual adapted immunosuppression, golden standard therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual adapted immunosuppressionDrug
individual adapted immunosuppression
golden standard therapyDrug
golden standard therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | individual adapted immunosuppression Receives: Drug: individual adapted immunosuppression |
| 2 | Active comparator | golden standard therapy Receives: Drug: golden standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft function as measured by Cr EDTA AUC
Measured: at 1 year
Secondary outcomes (24)
Graft survival
Measured: at 1 year
Patient survival
Measured: at 1 year
Graft function measured by estimated GFR (eGFR) (MDRD and Cockroft-Gault)
Measured: at 1 year
Frequency of biopsy proven acute rejection episodes
Measured: 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).
Measured: at 1 year
Incidence of rejection treated by antibodies (OKT3, ATG)
Measured: at 1 year
Time to first rejection (days)
Measured: at 1 year
Severity of rejection as assessed by BANFF 2005 score
Measured: at 1 year
Number of acute rejections per patient
Measured: at 1 year
Plasma creatinine and eGFR
Measured: at month 1, 3 and yearly (2 and 3 years)
Measured GFR
Measured: at month 3 and yearly
Proteinuria
Measured: at month 1, 3 and at 1 and 3 years
Incidence and score of borderline changes and acute rejection
Measured: in month 3 and month 12 biopsy
Incidence and score of chronic alloimmune injury/rejection and nonimmune injury
Measured: in month 3 and month 12 biopsies (BANFF 2005)
Development and evolution of glucose abnormalities
Measured: at 1 year
blood pressure
Measured: at 1 year
ambulatory 24-hr blood pressure monitoring
Measured: at 1 year and 3 years
Left ventricular mass assessed by echocardiography
Measured: at 1 year and 3 years
Fasting lipid profile
Measured: at baseline, month 1,3,6 and yearly
CMV infection (as measured with whole blood PCR) and disease
Measured: at 1 year
Polyoma virus replication as measured by whole blood PCR
Measured: at 1 year
Incidence of BK nephritis
Measured: in month 3 and month 12 biopsies
Incidence of PTLD and Nonmelanoma skin cancer
Measured: at 1 year and yearly
Incidence of EBV reactivation (as measured with whole blood PCR)
Measured: at 1 year and yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Raymond Vanholder, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895206
- Sponsor's protocol ID
- 2008/640
- Acronym
- CD4-01
- Status last verified
- Oct 2016
- First submitted
- 7 May 2009
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT00895206
- Acronym / sponsor ID
- CD4-01 / 2008/640
- Conditions
- Kidney Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- May 2009
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 8 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: individual adapted immunosuppressionindividual adapted immunosuppression |
| 2 | Active comparator | Drug: golden standard therapygolden standard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individual adapted immunosuppressionindividual adapted immunosuppression | Drug | 1 |
| golden standard therapygolden standard therapy | Drug | 2 |
Primary outcome
Graft function as measured by Cr EDTA AUC
Time frame: at 1 year
24 secondary outcomes
Graft survival
Time frame: at 1 year
Patient survival
Time frame: at 1 year
Graft function measured by estimated GFR (eGFR) (MDRD and Cockroft-Gault)
Time frame: at 1 year
Frequency of biopsy proven acute rejection episodes
Time frame: 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
Incidence of rejection treated by antibodies (OKT3, ATG)
Time frame: at 1 year
Time to first rejection (days)
Time frame: at 1 year
Severity of rejection as assessed by BANFF 2005 score
Time frame: at 1 year
Number of acute rejections per patient
Time frame: at 1 year
Plasma creatinine and eGFR
Time frame: at month 1, 3 and yearly (2 and 3 years)
Measured GFR
Time frame: at month 3 and yearly
Proteinuria
Time frame: 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
Incidence and score of chronic alloimmune injury/rejection and nonimmune injury
Time frame: in month 3 and month 12 biopsies (BANFF 2005)
Development and evolution of glucose abnormalities
Time frame: at 1 year
blood pressure
Time frame: at 1 year
ambulatory 24-hr blood pressure monitoring
Time frame: at 1 year and 3 years
Left ventricular mass assessed by echocardiography
Time frame: at 1 year and 3 years
Fasting lipid profile
Time frame: at baseline, month 1,3,6 and yearly
CMV infection (as measured with whole blood PCR) and disease
Time frame: at 1 year
Polyoma virus replication as measured by whole blood PCR
Time frame: at 1 year
Incidence of BK nephritis
Time frame: in month 3 and month 12 biopsies
Incidence of PTLD and Nonmelanoma skin cancer
Time frame: at 1 year and yearly
Incidence of EBV reactivation (as measured with whole blood PCR)
Time frame: at 1 year and yearly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- website of the University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Vanholder, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing individual adapted immunosuppression and golden standard therapy in people with Kidney Transplantation, run by University Hospital, Ghent at 1 site in Belgium.
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 4 inclusion and 13 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 13 Oct 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 Belgium. 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?
Graft function as measured by Cr EDTA AUC (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2016.