Kidney TransplantationPhase 4NCT00204191
Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation
A Phase 4 study testing tacrolimus in people with Kidney Transplantation, run by Uniwersytet Mikolaja Kopernika w Toruniu at 1 site in Poland.
Trial summary
The purpose of this study is to evaluate and compare, in the single center setting, the safety, efficacy and cost-effectiveness of the two standard immunosuppressive regimens based on tacrolimus and cyclosporine. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- tacrolimus
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- May 2003to Dec 2007
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First or second cadaveric kidney transplantation
- Age over 18 years old
- Specific indications or contraindications for cyclosporine or tacrolimus are absent
- Informed consent
Who cannot join
- Specific indications for use of cyclosporine or tacrolimus
- Specific contraindications for use of cyclosporine or tacrolimus
- Participation in another interventional clinical trial
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Klinika Transplantologii, Szpital Uniwersytecki, ul. M. Sklodowskiej-Curie 9
Bydgoszcz, 85-084
Zbigniew Wlodarczyk, MD
Andrzej Adamowicz, MD
About this study
Official title: Open, Prospective, Randomized Study to Compare the Efficacy and Safety of Immunosuppression Regimens Based on Cyclosporine (Neoral®) and Tacrolimus (Prograf®) in Renal Transplant Patients
The purpose of this study is to evaluate and compare, in the single center setting, the safety, efficacy and cost-effectiveness of the two standard immunosuppressive regimens based on tacrolimus and cyclosporine.
Read the detailed description
Despite several multicenter studies, there is no hard evidence on the superiority of a cyclosporine or tacrolimus based immunosuppressive regimen following kidney transplantation, in a single-center setting. Existing studies concentrated on benefits in safety and efficacy, but seldomly evaluated the cost-effectiveness of one treatment.
The study has been designed in a fashion as close to the daily clinical practice as possible. Patients are randomized in pairs, receiving kidneys from the same donor, thus avoiding donor-related bias. Those having specific indications or contraindications for one of the study medications were not entered into the study. All other study-related decisions are made only on a clinical basis and according to the standard practice of the center. Patients are followed on the intention-to-treat rule. Cost-effectiveness will be calculated on 12-month treatment for each patient entered into the study.
- Conditions
- Kidney Transplantation
- Being tested
- tacrolimus
- Keywords
- kidney transplantation, Immunosuppression, Cyclosporine, Tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
graft survival
Measured: at one year
patient survival
Measured: at one year
Secondary outcomes (3)
renal function measured by serum creatinine (SCr)
Measured: at one year
lipid profile
Measured: throughout the study
total cost of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2003
- Study completionDec 2007
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uniwersytet Mikolaja Kopernika w Toruniu
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Investigators
- Zbigniew Wlodarczyk, MD, PhD, Principal investigator, Klinika Transplantologii, Collegium Medicum UMK Torun
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204191
- Sponsor's protocol ID
- 1/25/03
- Other IDs
- IDS PL-02-RG-122
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 19 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Prospective, Randomized Study to Compare the Efficacy and Safety of Immunosuppression Regimens Based on Cyclosporine (Neoral®) and Tacrolimus (Prograf®) in Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT00204191
- Acronym / sponsor ID
- 1/25/03
- Conditions
- Kidney Transplantation
- Keywords
- kidney transplantation, Immunosuppression, Cyclosporine, Tacrolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Uniwersytet Mikolaja Kopernika w ToruniuUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- May 2003
- Study completion
- Dec 2007
- First posted
- 20 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.
The purpose of this study is to evaluate and compare, in the single center setting, the safety, efficacy and cost-effectiveness of the two standard immunosuppressive regimens based on tacrolimus and cyclosporine.
Detailed description
Despite several multicenter studies, there is no hard evidence on the superiority of a cyclosporine or tacrolimus based immunosuppressive regimen following kidney transplantation, in a single-center setting. Existing studies concentrated on benefits in safety and efficacy, but seldomly evaluated the cost-effectiveness of one treatment.
The study has been designed in a fashion as close to the daily clinical practice as possible. Patients are randomized in pairs, receiving kidneys from the same donor, thus avoiding donor-related bias. Those having specific indications or contraindications for one of the study medications were not entered into the study. All other study-related decisions are made only on a clinical basis and according to the standard practice of the center. Patients are followed on the intention-to-treat rule. Cost-effectiveness will be calculated on 12-month treatment for each patient entered into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First or second cadaveric kidney transplantation
- Age over 18 years old
- Specific indications or contraindications for cyclosporine or tacrolimus are absent
- Informed consent
Key exclusion criteria (4 listed)
- Specific indications for use of cyclosporine or tacrolimus
- Specific contraindications for use of cyclosporine or tacrolimus
- Participation in another interventional clinical trial
- Pregnancy or lactation
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 |
|---|---|---|
| tacrolimus | Drug | – |
Primary outcome
graft survival
Time frame: at one year
patient survival
Time frame: at one year
3 secondary outcomes
renal function measured by serum creatinine (SCr)
Time frame: at one year
lipid profile
Time frame: throughout the study
total cost of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2007.
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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.
Zbigniew Wlodarczyk, MD, PhD principal investigator
Klinika Transplantologii, Collegium Medicum UMK Torun
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 tacrolimus in people with Kidney Transplantation, run by Uniwersytet Mikolaja Kopernika w Toruniu at 1 site in Poland.
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 4 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: status not confirmed, as of the sponsor's last update on 19 Oct 2007. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zbigniew Wlodarczyk, MD, PhD (+48 52 585 4044, kiktranspl@cm.umk.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
graft survival (time frame: at one year). The study lists 2 primary outcomes in all. 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 19 Oct 2007.