Renal Transplant Graft FailurePharmCareNCT02402140
Influence of Pharmaceutical Care on the Intraindividual Variability of Tacrolimus Concentrations
A study testing Pharmaceutical Intervention in people with Renal Transplant Graft Failure, run by Hospital do Rim e Hipertensão.
Trial summary
Primary end-point The primary end-point was the influence of pharmaceutical intervention in tacrolimus intra-subject variability during the first 3 months after kidney transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant Graft Failure
- What is being tested?
- Pharmaceutical Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Dec 2014
- Phase
- Interventional
- 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
- patients who underwent renal transplantation aged ≥18 years old,
- who signed the informed consent,
- who underwent follow-up post transplant clinic at the Hospital do Rim for 3 months,
- receiving immunosuppressive drugs tacrolimus, prednisone and sodium mycophenolate or tacrolimus, azathioprine, and prednisone.
Who cannot join
- were patients who underwent second kidney transplant,
- which did not follow the Hospital do Rim after transplant and who were participating in some other study with pharmaceutical intervention.
About this study
Official title: A Prospective Randomized Trial Investigating the Influence of Pharmaceutical Care on the Intraindividual Variability of Tacrolimus Concentrations Early After Kidney Transplant.
Primary end-point
The primary end-point was the influence of pharmaceutical intervention in tacrolimus intra-subject variability during the first 3 months after kidney transplant. Coefficients of variation were calculated from the average of dose-corrected tacrolimus blood concentration(CV= Standard Deviation (SD) x 100/mean) of study visits day 10, 14, 21, 30, 60 and 90 post kidney transplant.
Read more
Secondary end-points
- Secondary outcomes included evaluate percentage of patients who achieved target levels of tacrolimus in day study visits 7, 10, 14, 21, 28, 60 e 90 days after kidney transplant;
- Tacrolimus bioavailability profile during the period of 3 months,characterized by mean and standard deviation (SD) of dose corrected tacrolimus blood concentration(ng/ml/mg);
- Assess patient adherence through validated questionnaire "Portuguese version of Basel Scale Adherence Rating Immunosuppressive Drugs (BAASIS) scale". It consists of a four-item questionnaire measuring nonadherence to immunosuppressives over the past four weeks. This questionnaire assesses omission of single doses or successive doses, timing deviations >2h and dose reductions. Responses are given on a six-point scale: never, once per month, every second week, every week, more than once per week and every day. Patients that answer different from "never" in any of the four questions are considered as nonadherent;
- We evaluated renal function eGFR by Modification of Diet in Renal Disease (MDRD);
- We evaluated Incidence of Infections;
- We evaluated Treated acute rejection episodes;
- We evaluated Death cases;
- We evaluated Graft loss cases;
- We evaluated Discontinuation of immunosuppressive treatment;
- We evaluated Hospital readmissions.
Study Design
This was a single-center, prospective, randomized and controlled study to evaluate the influence of pharmaceutical intervention in tacrolimus intra-subject variability during the first 3 months after transplantation. The authors designed the protocol, acquired and maintained the data, and conducted the statistical analysis. The protocol was approved by an independent ethics committee. All subjects signed a written informed consent before enrollment and the study was conducted according to good clinical practices and declaration of Helsinki. This study was conducted at Hospital do Rim between February 2014 and December 2014, 128 randomized and were followed for 3 months after transplantation.
Read the detailed description
Population
Inclusion criteria were patients who underwent renal transplantation aged ≥18 years old, who signed the informed consent, who underwent follow-up post transplant clinic at the Hospital do Rim for 3 months, receiving immunosuppressive drugs tacrolimus, prednisone and sodium mycophenolate or tacrolimus, azathioprine, and prednisone. Exclusion criteria were patients who underwent second kidney transplant, which did not follow the Hospital do Rim after transplant and who were participating in some other study with pharmaceutical intervention.
Randomization The randomization plan was carried out in blocks and stratified by immunosuppressive drugs tacrolimus, prednisone and mycophenolate sodium or tacrolimus, prednisone and azathioprine.
Opaque envelopes were made from a table of random numbers and they were open on the day of randomization to determine the group to which each patient was allocated group 1 with pharmaceutical intervention or group 2 without pharmaceutical intervention.
- Conditions
- Renal Transplant Graft Failure
- Being tested
- Pharmaceutical Intervention
- Keywords
- tacrolimus blood concentration, pharmaceutical intervention, intrasubject variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical InterventionOther
Patients allocated to group 1, with pharmaceutical intervention, received instructions on the proper use of immunosuppressants as doses, frequency, importance, schedules on the following days 3, 5, 7, 10, 14, 21, 28, 60 and 90 after kidney transplant. Teaching materials were designed to assist in the pharmaceutical guidelines that understood the importance of immunosuppressive drugs, the risk of rejection, the schedules and the most appropriate way for the administration. In addition to these guidelines, pharmacists helped patients in filling out the patient diary. This diary contains all the medications that the patient administers and encourages them to write down daily doses in order to remind them. This was a standardized pharmacist intervention.
| Study group | Role | What they receive |
|---|---|---|
| 1 with pharmaceutical intervention | Experimental | Patients allocated to group 1 with pharmaceutical intervention received instructions on the proper use of immunosuppressants as dosage, frequency and administration schedules, importance of immunosuppressive drugs and the risk of rejection.
No more interventions were applied. Receives: Other: Pharmaceutical Intervention |
| 2 without pharmaceutical intervention | No intervention | Standard following of the Hospital do Rim, without pharmaceutical intervention. This group was just followed by the nurses of the hospital, but without a standardized intervention. It was not a intervention, it was the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end-point was the influence of pharmaceutical intervention in tacrolimus intra-subject variability during the first 3 months after kidney transplant. variability during the first 3 months after transplantation.
Coefficients of variation were calculated from the average of dose-corrected tacrolimus blood concentration(CV= SD x 100/mean) of study visits day 10, 14, 21, 30, 60 and 90 post kidney transplant.
Measured: 3 months
Secondary outcomes (10)
Assess patient adherence through validated questionnaire "Portuguese version of BAASIS scale (Basel Scale Adherence Rating Immunosuppressive Drugs)";
It consists of a four-item questionnaire measuring nonadherence to immunosuppressives over the past four weeks. This questionnaire assesses omission of single doses or successive doses, timing deviations >2h and dose reductions. Responses are given on a six-point scale: never, once per month, every second week, every week, more than once per week and every day. Patients that answer different from "never" in any of the four questions are considered as nonadherent.
Measured: 3 months
Secondary outcomes included evaluate percentage of patients who achieved target levels of tacrolimus in day study visits day 7, 10, 14, 21, 28, 60 e 90 post kidney transplant
Measured: 3 months
We also evaluated renal function (eGFR by MDRD formula)
Measured: 3 months
Tacrolimus bioavailability profile during the period of 3 months
Characterized by mean and standard deviation of dose corrected tacrolimus blood concentrations(ng/ml/mg)
Measured: 3 months
We evaluated the incidence of Infections
Measured: 3 months
We evaluated treated acute rejection episodes
Measured: 3 months
We evaluated death cases
Measured: 3 months
We evaluated graft loss cases
Measured: 3 months
We evaluated discontinuation of immunosuppressive treatment
Measured: 3 months
We evaluated hospital readmissions.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startFeb 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Transplant Graft FailureStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Rim e Hipertensão
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrieli Barros Bessa, Hospital do Rim e Hipertensão
- Investigators
- Adrieli BA Bessa, Pharmacist, Principal investigator, Hospital do Rim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402140
- Sponsor's protocol ID
- Hospital do Rim
- Acronym
- PharmCare
- Status last verified
- Oct 2015
- First submitted
- 6 Mar 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
PubMed 36094829
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Investigating the Influence of Pharmaceutical Care on the Intraindividual Variability of Tacrolimus Concentrations Early After Kidney Transplant.
- ClinicalTrials.gov ID
- NCT02402140
- Acronym / sponsor ID
- PharmCare / Hospital do Rim
- Conditions
- Renal Transplant Graft Failure
- Keywords
- tacrolimus blood concentration, pharmaceutical intervention, intrasubject variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Hospital do Rim e HipertensãoUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Mar 2015 (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.
Primary end-point
The primary end-point was the influence of pharmaceutical intervention in tacrolimus intra-subject variability during the first 3 months after kidney transplant. Coefficients of variation were calculated from the average of dose-corrected tacrolimus blood concentration(CV= Standard Deviation (SD) x 100/mean) of study visits day 10, 14, 21, 30, 60 and 90 post kidney transplant.
Secondary end-points
- Secondary outcomes included evaluate percentage of patients who achieved target levels of tacrolimus in day study visits 7, 10, 14, 21, 28, 60 e 90 days after kidney transplant;
- Tacrolimus bioavailability profile during the period of 3 months,characterized by mean and standard deviation (SD) of dose corrected tacrolimus blood concentration(ng/ml/mg);
- Assess patient adherence through validated questionnaire "Portuguese version of Basel Scale Adherence Rating Immunosuppressive Drugs (BAASIS) scale". It consists of a four-item questionnaire measuring nonadherence to immunosuppressives over the past four weeks. This questionnaire assesses omission of single doses or successive doses, timing deviations >2h and dose reductions. Responses are given on a six-point scale: never, once per month, every second week, every week, more than once per week and every day. Patients that answer different from "never" in any of the four questions are considered as nonadherent;
- We evaluated renal function eGFR by Modification of Diet in Renal Disease (MDRD);
- We evaluated Incidence of Infections;
- We evaluated Treated acute rejection episodes;
- We evaluated Death cases;
- We evaluated Graft loss cases;
- We evaluated Discontinuation of immunosuppressive treatment;
- We evaluated Hospital readmissions.
Study Design
This was a single-center, prospective, randomized and controlled study to evaluate the influence of pharmaceutical intervention in tacrolimus intra-subject variability during the first 3 months after transplantation. The authors designed the protocol, acquired and maintained the data, and conducted the statistical analysis. The protocol was approved by an independent ethics committee. All subjects signed a written informed consent before enrollment and the study was conducted according to good clinical practices and declaration of Helsinki. This study was conducted at Hospital do Rim between February 2014 and December 2014, 128 randomized and were followed for 3 months after transplantation.
Detailed description
Population
Inclusion criteria were patients who underwent renal transplantation aged ≥18 years old, who signed the informed consent, who underwent follow-up post transplant clinic at the Hospital do Rim for 3 months, receiving immunosuppressive drugs tacrolimus, prednisone and sodium mycophenolate or tacrolimus, azathioprine, and prednisone. Exclusion criteria were patients who underwent second kidney transplant, which did not follow the Hospital do Rim after transplant and who were participating in some other study with pharmaceutical intervention.
Randomization The randomization plan was carried out in blocks and stratified by immunosuppressive drugs tacrolimus, prednisone and mycophenolate sodium or tacrolimus, prednisone and azathioprine.
Opaque envelopes were made from a table of random numbers and they were open on the day of randomization to determine the group to which each patient was allocated group 1 with pharmaceutical intervention or group 2 without pharmaceutical intervention.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 with pharmaceutical intervention | Experimental | Other: Pharmaceutical InterventionPatients allocated to group 1 with pharmaceutical intervention received instructions on the proper use of immunosuppressants as dosage, frequency and administration schedules, importance of immunosuppressive drugs and the risk of rejection. No more interventions were applied. |
| 2 without pharmaceutical intervention | No intervention | –Standard following of the Hospital do Rim, without pharmaceutical intervention. This group was just followed by the nurses of the hospital, but without a standardized intervention. It was not a intervention, it was the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients who underwent renal transplantation aged ≥18 years old,
- who signed the informed consent,
- who underwent follow-up post transplant clinic at the Hospital do Rim for 3 months,
- receiving immunosuppressive drugs tacrolimus, prednisone and sodium mycophenolate or tacrolimus, azathioprine, and prednisone.
Key exclusion criteria (2 listed)
- were patients who underwent second kidney transplant,
- which did not follow the Hospital do Rim after transplant and who were participating in some other study with pharmaceutical intervention.
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 |
|---|---|---|
| Pharmaceutical InterventionPatients allocated to group 1, with pharmaceutical intervention, received instructions on the proper use of immunosuppressants as doses, frequency, importance, schedules on the following days 3, 5, 7, 10, 14, 21, 28, 60 and 90 after kidney transplant. Teaching materials were designed to assist in the pharmaceutical guidelines that understood the importance of immunosuppressive drugs, the risk of rejection, the schedules and the most appropriate way for the administration. In addition to these guidelines, pharmacists helped patients in filling out the patient diary. This diary contains all the medications that the patient administers and encourages them to write down daily doses in order to remind them. This was a standardized pharmacist intervention. | Other | 1 with pharmaceutical intervention |
Primary outcome
The primary end-point was the influence of pharmaceutical intervention in tacrolimus intra-subject variability during the first 3 months after kidney transplant. variability during the first 3 months after transplantation.
Time frame: 3 months
Coefficients of variation were calculated from the average of dose-corrected tacrolimus blood concentration(CV= SD x 100/mean) of study visits day 10, 14, 21, 30, 60 and 90 post kidney transplant.
10 secondary outcomes
Assess patient adherence through validated questionnaire "Portuguese version of BAASIS scale (Basel Scale Adherence Rating Immunosuppressive Drugs)";
Time frame: 3 months
Secondary outcomes included evaluate percentage of patients who achieved target levels of tacrolimus in day study visits day 7, 10, 14, 21, 28, 60 e 90 post kidney transplant
Time frame: 3 months
We also evaluated renal function (eGFR by MDRD formula)
Time frame: 3 months
Tacrolimus bioavailability profile during the period of 3 months
Time frame: 3 months
We evaluated the incidence of Infections
Time frame: 3 months
We evaluated treated acute rejection episodes
Time frame: 3 months
We evaluated death cases
Time frame: 3 months
We evaluated graft loss cases
Time frame: 3 months
We evaluated discontinuation of immunosuppressive treatment
Time frame: 3 months
We evaluated hospital readmissions.
Time frame: 3 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 3 Nov 2015.
- Derived from this study: PubMed 36094829Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
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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.
Adrieli BA Bessa, Pharmacist principal investigator
Hospital do Rim
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical Intervention in people with Renal Transplant Graft Failure, run by Hospital do Rim e Hipertensão.
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 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 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The primary end-point was the influence of pharmaceutical intervention in tacrolimus intra-subject variability during the first 3 months after kidney transplant. variability during the first 3 months after transplantation. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02402140, which also lists 1 linked publication.
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 3 Nov 2015.