Kidney TransplantationPhase 4NCT00717379
Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
A Phase 4 study testing Tacrolimus, Mycophenolate Mofetil and Methylprednisolone or equivalent in people with Kidney Transplantation and Kidney Failure, Chronic, run by Astellas Pharma Inc at 6 sites in Russia.
Trial summary
To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Kidney Failure, Chronic, Renal Insufficiency, Chronic
- What is being tested?
- Tacrolimus, Mycophenolate Mofetil and Methylprednisolone or equivalent
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesRussia
- Study dates
- May 2007to Oct 2008
- 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
- Female subject of childbearing potential must have a negative serum pregnancy test at enrolment and must agree to maintain effective birth control during the study
- Has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation
- Subject is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible AB0 blood type
Who cannot join
- Pregnant woman or breast-feeding mother
- Has an immunological high risk, defined as having a most recently measured PRA grade of > 50% within the previous six months
- Known allergy to the study drug or any of its components
- Requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation
- Requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
- Subject or donor is known to be HIV positive
Show all 13Show fewer
- Has significant liver disease, defined as having during the past 28 days continuously elevated ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
- Diagnosis of malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
- Has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
- Previously received or is receiving an organ transplant other than kidney
- Receiving a graft from a non-heart-beating donor
- Cold ischemia time of the donor kidney >30 hours
- Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
Study site
Moscow, 115446
Study site
Moscow, 119992
Study site
Moscow, 123182
Study site
Omsk, 644112
Study site
Saint Petersburg, 197110
Study site
Volzskii, 404120
About this study
Official title: Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population.
- Being tested
- Tacrolimus, Mycophenolate Mofetil, Methylprednisolone or equivalent, Prednisone
- Keywords
- Organ Transplantation, Tacrolimus, Prograf, Kidney, Immunosuppression
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograf, FK506
oral
Also called MMF
oral
Methylprednisolone or equivalentDrug
oral
PrednisoneDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | steroid regimen 1 Receives: Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Drug: Methylprednisolone or equivalent; Drug: Prednisone |
| 2 | Experimental | steroid regimen 2 Receives: Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Drug: Methylprednisolone or equivalent; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and time to first biopsy-proven acute rejection
Measured: 6 months
Secondary outcomes (4)
Overall frequency of acute rejection episodes within 6 months post transplantation
Measured: 6 months
Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation
Measured: 6 months
Incidence of and time to first corticosteroid-resistant acute rejection
Measured: 6 months
Subject and graft survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startMay 2007
- Primary completionOct 2008
- Study completionOct 2008
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Central Contact, Study director, ZAO Astellas Pharma Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717379
- Sponsor's protocol ID
- PRG-EC-2R01
- Status last verified
- Apr 2009
- First submitted
- 16 Jul 2008
- Last updated
- 15 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00717379
- Acronym / sponsor ID
- PRG-EC-2R01
- Keywords
- Organ Transplantation, Tacrolimus, Prograf, Kidney, Immunosuppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 17 Jul 2008 (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.
To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Tacrolimus, Drug: Mycophenolate Mofetil, Drug: Methylprednisolone or equivalent, Drug: Prednisonesteroid regimen 1 |
| 2 | Experimental | Drug: Tacrolimus, Drug: Mycophenolate Mofetil, Drug: Methylprednisolone or equivalent, Drug: Prednisonesteroid regimen 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female subject of childbearing potential must have a negative serum pregnancy test at enrolment and must agree to maintain effective birth control during the study
- Has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation
- Subject is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible AB0 blood type
Key exclusion criteria (13 listed)
- Pregnant woman or breast-feeding mother
- Has an immunological high risk, defined as having a most recently measured PRA grade of > 50% within the previous six months
- Known allergy to the study drug or any of its components
- Requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation
- Requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
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 |
|---|---|---|
| TacrolimusAlso: Prograf, FK506oral | Drug | 1, 2 |
| Mycophenolate MofetilAlso: MMForal | Drug | 1, 2 |
| Methylprednisolone or equivalentoral | Drug | 1, 2 |
| Prednisoneoral | Drug | 1, 2 |
Primary outcome
Incidence and time to first biopsy-proven acute rejection
Time frame: 6 months
4 secondary outcomes
Overall frequency of acute rejection episodes within 6 months post transplantation
Time frame: 6 months
Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation
Time frame: 6 months
Incidence of and time to first corticosteroid-resistant acute rejection
Time frame: 6 months
Subject and graft survival
Time frame: 6 months
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 15 Apr 2009.
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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.
Central Contact study director
ZAO Astellas Pharma Russia
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus, Mycophenolate Mofetil and Methylprednisolone or equivalent in people with Kidney Transplantation and Kidney Failure, Chronic, run by Astellas Pharma Inc at 6 sites in Russia.
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 3 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 15 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia. 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?
Incidence and time to first biopsy-proven acute rejection (time frame: 6 months). 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 15 Apr 2009; AzTrials last refreshed its copy on 8 Nov 2026.