Immunosuppression After Kidney TransplantationPeliconNCT01904045
PEL-1235_REN-0176-I (Pelicon)
An observational study of Immunosuppression After Kidney Transplantation, run by Technical University of Munich at 1 site in Germany.
Trial summary
Aim of this study is to investigate whether in patients following kidney transplantation (>6 months after transplantation), the intra-patient variability of levels of tacrolimus is comparable after administration of tacrolimus twice daily (Prograf) to tacrolimus once daily (Advagraf), with each regimen for 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunosuppression After Kidney Transplantation
- What is being tested?
- tacrolimus Advagraf and tacrolimus Prograf
- How many people
- 51 participants
- Where
- 1 siteGermany
- Study dates
- May 2013to Aug 2018
- Phase
- Observational
- 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
Study population: Outpatient clinic
Who may be able to join
- signed written informed consent
- male or female patient ≥ 18years of age
- Patient has received a kidney transplantation at least 6 months prior to inclusion into the study
- No acute rejection episodes for at least 3 months
- PRG through level and dosing stable for at least 1 month
- Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study
Who cannot join
- Acute rejection episodes within the last 3 months prior to study entry
- Unstable PRG trough level or dose change in the month before study entry
- History of noncompliance to medical regimens
- Patients unwilling to or unable to comply with the protocol
- Treatment with another investigational product during this study or during the last 30 days prior to study start
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum rechts der Isar, Department of Nephrology
Munich, Bavaria, 81675
About this study
Official title: A Multicentre, Prospective, Non-Interventional Study to Assess the Intra-patient Variability of Tacrolimus Once and Twice Daily After Kidney Transplantation
Aim of this study is to investigate whether in patients following kidney transplantation (>6 months after transplantation), the intra-patient variability of levels of tacrolimus is comparable after administration of tacrolimus twice daily (Prograf) to tacrolimus once daily (Advagraf), with each regimen for 3 months.
- Being tested
- tacrolimus Advagraf, tacrolimus Prograf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimus AdvagrafOther
intake of Advagraf once daily for 3 months
tacrolimus PrografOther
intake of Prograf twice daily for 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrapatient variability of tacrolimus through level
Measured: pre-dose, 1 h post dose and 3 h post dose for 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunosuppression After 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904045
- Sponsor's protocol ID
- PEL-1235_REN-0176-I
- Acronym
- Pelicon
- Status last verified
- Sep 2018
- First submitted
- 2 Jul 2013
- Last updated
- 13 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Non-Interventional Study to Assess the Intra-patient Variability of Tacrolimus Once and Twice Daily After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT01904045
- Acronym / sponsor ID
- Pelicon / PEL-1235_REN-0176-I
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 22 Jul 2013 (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.
Aim of this study is to investigate whether in patients following kidney transplantation (>6 months after transplantation), the intra-patient variability of levels of tacrolimus is comparable after administration of tacrolimus twice daily (Prograf) to tacrolimus once daily (Advagraf), with each regimen for 3 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinic
Key inclusion criteria (6 listed)
- signed written informed consent
- male or female patient ≥ 18years of age
- Patient has received a kidney transplantation at least 6 months prior to inclusion into the study
- No acute rejection episodes for at least 3 months
- PRG through level and dosing stable for at least 1 month
Key exclusion criteria (5 listed)
- Acute rejection episodes within the last 3 months prior to study entry
- Unstable PRG trough level or dose change in the month before study entry
- History of noncompliance to medical regimens
- Patients unwilling to or unable to comply with the protocol
- Treatment with another investigational product during this study or during the last 30 days prior to study start
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 Advagrafintake of Advagraf once daily for 3 months | Other | – |
| tacrolimus Prografintake of Prograf twice daily for 3 months | Other | – |
Primary outcome
Intrapatient variability of tacrolimus through level
Time frame: pre-dose, 1 h post dose and 3 h post dose for 3 month
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 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunosuppression After Kidney Transplantation, run by Technical University of Munich at 1 site in Germany.
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 6 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 13 Sep 2018. 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 Germany. 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.
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?
Intrapatient variability of tacrolimus through level (time frame: pre-dose, 1 h post dose and 3 h post dose for 3 month). 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 Sep 2018.