Kidney TransplantationPhase 2NCT00189735
A Study to Evaluate FK778 in Kidney Transplant Patients
A Phase 2 study testing FK778 in people with Kidney Transplantation and Renal Transplantation, run by Astellas Pharma Inc at 37 sites in 12 countries.
Trial summary
A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Renal Transplantation, Transplantation, Renal
- What is being tested?
- FK778
- How many people
- 364 participants
- Where
- 37 sitesin 12 countries
- Study dates
- Sep 2003to Oct 2005
- Phase
- Phase 2
- 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
- Patient has end stage kidney disease or needs retransplantation (loss of graft for non-immunological reasons).
- Patient has been fully informed.
Who cannot join
- Patient has an immunological high risk and/or having a previous graft survival shorter than 1 year due to immunological reasons.
- Patient has significant liver disease.
- Cold ischemia time of the donor kidney >28 hours.
- Patient having uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
- Patient has previously received or is receiving an organ transplant other than kidney.
Trial locations and contacts
37 sites in 12 countries.
37 sites in 12 countries
France8 sites
Study site
Brest, 29 200
Study site
Créteil, 94010
Study site
Grenoble
Study site
Le Kremlin-Bicêtre, 94275
Study site
Montpellier, 34295
Study site
Rennes, 35003
Study site
Saint-Etienne, 42055
Study site
Toulouse, 31 403
Spain8 sites
Study site
Barcelona, 08025
Study site
Barcelona, 08036
Study site
Barcelona, 08907
Study site
Córdoba, 14004
Study site
Madrid, 28034
Study site
Madrid, 28041
Study site
Santander, 39008
Study site
Valencia, 46009
Germany7 sites
Study site
Berlin, 10117
Study site
Berlin, 13353
Study site
Essen, 45122
Study site
Frankfurt, 60590
Study site
Halle, 06112
Study site
München, 81675
Study site
Regensburg, 93053
Belgium3 sites
Study site
Brussels, 1070
Study site
Brussels, 1200
Study site
Leuven, 3000
Italy3 sites
Study site
Padova, 35128
Study site
Roma, 00168
Study site
Torino, 10126
About this study
Official title: A Multicentre, Randomised, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Different Concentrations of FK778 With Tacrolimus (FK506) and Steroids Versus a Standard Regimen of Tacrolimus, MMF and Steroids in Renal Transplant Patients
A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients
- Conditions
- Kidney Transplantation, Renal Transplantation, Transplantation, Renal, Transplantation, Kidney, Grafting, Kidney
- Being tested
- FK778
- Keywords
- Treatment Efficacy, Treatment Effectiveness, Anti-rejection therapy, Immunosuppression, Antirejection, Malononitrilamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK778Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of biopsy-proven acute rejection over the first 24 weeks.
Secondary outcomes (19)
Efficacy:Incidence of and time to first biopsy-proven acute rejection over the first 24 weeks and after 1 year
Incidence of and time to first corticosteroid-resistant acute rejections over the first 24 weeks and after 1 year
Incidence of and time to first acute rejection by signs and symptoms over the first 24 weeks and after 1 year
Severity of biopsy-proven acute rejections (Banff criteria) over the first 24 weeks and after 1 year
Frequency of treatment failure (as defined below) over the first 24 weeks and after 1 year
Renal function as measured by serum creatinine concentrations and calculated creatinine clearance (Cockcroft formula) over the first 24 weeks and after 1 year
Chronic allograft dysfunction assessed by chronic allograft damage index (CADI) after 24 weeks of transplantation.
Safety first 24 weeks: Patient survival
Graft survival
Incidence of adverse events
Routine safety laboratory parameters
Haemoglobin values at weeks two to six
Leukocytes at weeks two to six
Thrombocytes at weeks two to six
Bilirubin at weeks two to six
Incidence of CMV viraemia
Incidence of Diarrhoea, Gastroenteritis and Gastritis
Safety after 1 year:Incidence of adverse events
Patient and graft survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionOct 2005
- Study completionOct 2005
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V.
- Investigators
- H. H. Neumayer, Principal investigator, Universitätsklinik Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189735
- Sponsor's protocol ID
- FG-778-02-60
- Status last verified
- Apr 2008
- First submitted
- 12 Sep 2005
- Last updated
- 17 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Different Concentrations of FK778 With Tacrolimus (FK506) and Steroids Versus a Standard Regimen of Tacrolimus, MMF and Steroids in Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT00189735
- Acronym / sponsor ID
- FG-778-02-60
- Conditions
- Kidney Transplantation, Renal Transplantation, Transplantation, Renal, Transplantation, Kidney, Grafting, Kidney
- Keywords
- Treatment Efficacy, Treatment Effectiveness, Anti-rejection therapy, Immunosuppression, Antirejection, Malononitrilamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V.
- Study start
- Sep 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 19 Sep 2005 (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.
A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has end stage kidney disease or needs retransplantation (loss of graft for non-immunological reasons).
- Patient has been fully informed.
Key exclusion criteria (5 listed)
- Patient has an immunological high risk and/or having a previous graft survival shorter than 1 year due to immunological reasons.
- Patient has significant liver disease.
- Cold ischemia time of the donor kidney >28 hours.
- Patient having uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
- Patient has previously received or is receiving an organ transplant other than kidney.
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 |
|---|---|---|
| FK778 | Drug | – |
Primary outcome
Incidence of biopsy-proven acute rejection over the first 24 weeks.
19 secondary outcomes
Efficacy:Incidence of and time to first biopsy-proven acute rejection over the first 24 weeks and after 1 year
Incidence of and time to first corticosteroid-resistant acute rejections over the first 24 weeks and after 1 year
Incidence of and time to first acute rejection by signs and symptoms over the first 24 weeks and after 1 year
Severity of biopsy-proven acute rejections (Banff criteria) over the first 24 weeks and after 1 year
Frequency of treatment failure (as defined below) over the first 24 weeks and after 1 year
Renal function as measured by serum creatinine concentrations and calculated creatinine clearance (Cockcroft formula) over the first 24 weeks and after 1 year
Chronic allograft dysfunction assessed by chronic allograft damage index (CADI) after 24 weeks of transplantation.
Safety first 24 weeks: Patient survival
Graft survival
Incidence of adverse events
Routine safety laboratory parameters
Haemoglobin values at weeks two to six
Leukocytes at weeks two to six
Thrombocytes at weeks two to six
Bilirubin at weeks two to six
Incidence of CMV viraemia
Incidence of Diarrhoea, Gastroenteritis and Gastritis
Safety after 1 year:Incidence of adverse events
Patient and graft survival
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 17 Apr 2008.
Related trials for Kidney Transplantation
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A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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.
H. H. Neumayer principal investigator
Universitätsklinik Charité
37 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FK778 in people with Kidney Transplantation and Renal Transplantation, run by Astellas Pharma Inc at 37 sites in 12 countries.
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 2 inclusion and 5 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 17 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France, Spain, Germany, Belgium, Italy and 7 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of biopsy-proven acute rejection over the first 24 weeks.. 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 17 Apr 2008.