Chronic Kidney InsufficiencyNCT01353417
Non-interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Renal Graft Rejection
An observational study of Chronic Kidney Insufficiency, run by Sandoz at 1 site in Austria.
Trial summary
This non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the approved indication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Insufficiency
- What is being tested?
- In this observational study no study specific intervention is planned
- Type of treatment
- Pill or oral medicine
- How many people
- 102 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2011to 31 Aug 2015
- 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: Patients after renal transplantation who are treated in the general hospital of Vienna on an outpatient basis
Who may be able to join
- Age: ≥ 18
- Post renal transplantation time: ≥ 6 months
- Stable kidney function ( serum creatinine < 3.0mg/dl; variation < 0.5mg/dl at 2 appointments in minimum distance of 6 days)
- Stable Tacrolimus Sandoz© dose > 2 weeks before inclusion in this Non Interventional Study (NIS)
- Written and oral informed consent
Who cannot join
- Well-known poor compliance with immunosuppressives
- Acute rejection reaction within the past 3 months or antibody-therapy because of rejection within the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-site, Prospective Non-interventional-study With Adport Sandoz© Capsules for Prophylaxis of Graft Rejection in Patients With Stable Kidney Function After Renal Allograft.
This non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the approved indication.
- Conditions
- Chronic Kidney Insufficiency
- Being tested
- In this observational study no study specific intervention is planned
- Keywords
- Grafting, kidney, Transplantation, kidney
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In this observational study no study specific intervention is plannedOther
Patients with stable kidney function who already receive Tacrolimus Sandoz© capsules before being included in this non-interventional study, are being observed for 6 months by their attending physicians. Routine medical treatment is provided.
| Study group | Role | What they receive |
|---|---|---|
| Renal allograft | Not described Receives: Other: In this observational study no study specific intervention is planned |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Adport Sandoz© trough level
Measured: Observation time: 26 weeks
Secondary outcomes (4)
Efficacy of Adport Sandoz© in prevention of renal graft rejection by observing serum creatinine levels
Measured: Observation time: 26 weeks
Incidence of serious adverse drug reactions
Measured: Observation time: 26 weeks
Incidence of adverse drug reactions
Measured: Observation time: 26 weeks
Incidence of serious adverse events
Measured: Observation time: 26weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study startApr 2011
- Primary completion31 Aug 2015
- Study completion31 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney InsufficiencyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353417
- Sponsor's protocol ID
- TAC SAN NIS 2011
- Status last verified
- Apr 2017
- First submitted
- 12 May 2011
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-site, Prospective Non-interventional-study With Adport Sandoz© Capsules for Prophylaxis of Graft Rejection in Patients With Stable Kidney Function After Renal Allograft.
- ClinicalTrials.gov ID
- NCT01353417
- Acronym / sponsor ID
- TAC SAN NIS 2011
- Conditions
- Chronic Kidney Insufficiency
- Keywords
- Grafting, kidney, Transplantation, kidney
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 31 Aug 2015 (actual)
- First posted
- 13 May 2011 (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 non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the approved indication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal allograft | – | Other: In this observational study no study specific intervention is planned |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after renal transplantation who are treated in the general hospital of Vienna on an outpatient basis
Key inclusion criteria (5 listed)
- Age: ≥ 18
- Post renal transplantation time: ≥ 6 months
- Stable kidney function ( serum creatinine < 3.0mg/dl; variation < 0.5mg/dl at 2 appointments in minimum distance of 6 days)
- Stable Tacrolimus Sandoz© dose > 2 weeks before inclusion in this Non Interventional Study (NIS)
- Written and oral informed consent
Key exclusion criteria (2 listed)
- Well-known poor compliance with immunosuppressives
- Acute rejection reaction within the past 3 months or antibody-therapy because of rejection within the past 6 months
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 |
|---|---|---|
| In this observational study no study specific intervention is plannedPatients with stable kidney function who already receive Tacrolimus Sandoz© capsules before being included in this non-interventional study, are being observed for 6 months by their attending physicians. Routine medical treatment is provided. | Other | Renal allograft |
Primary outcome
Changes in Adport Sandoz© trough level
Time frame: Observation time: 26 weeks
4 secondary outcomes
Efficacy of Adport Sandoz© in prevention of renal graft rejection by observing serum creatinine levels
Time frame: Observation time: 26 weeks
Incidence of serious adverse drug reactions
Time frame: Observation time: 26 weeks
Incidence of adverse drug reactions
Time frame: Observation time: 26 weeks
Incidence of serious adverse events
Time frame: Observation time: 26weeks
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 7 Apr 2017.
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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 Chronic Kidney Insufficiency, run by Sandoz at 1 site in Austria.
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 5 inclusion and 2 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 7 Apr 2017. 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 Austria. 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?
Changes in Adport Sandoz© trough level (time frame: Observation time: 26 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 7 Apr 2017.