Kidney TransplantationNCT00148174
Predictors and Intervention for Noncompliance
A study testing Intensive telephone followup in people with Kidney Transplantation, run by University of Minnesota at 1 site in United States.
Trial summary
This is a randomized controlled intervention trial in poorly compliant patients, testing whether improved compliance behavior decreases rates of acute rejection risk and graft loss. Hypothesis: A study of an intensive intervention focused on the least compliant patients and beginning 3 months post-transplant. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Intensive telephone followup
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1998to 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Kidney transplant
- Discharged from hospital with functioning graft
Who cannot join
- Risk of recurrent primary renal disease, e.g. hemolytic uremic syndrome, oxalosis, membranoproliferative glomerulonephritis type II, focal,segmental glomerulosclerosis with nephrotic syndrome
- Patients with active psychosis
- Patients not using azathioprine, sirolimus, or mycophenolate mofetil for immunosuppression at the time of discharge
- Patients taking the liquid form of azathioprine or mycophenolate mofetil
- Patients who are younger than 14 yrs. old
- Patients who do not speak English
Show all 10Show fewer
- Receiving extra-renal organ except for pancreas,either simultaneously or previously
- Patients who live and will be followed outside of the United States, except Canada
- Patients who are physically unable to open the Medication Event Monitoring System(MEMS)cap
- Patients who are not responsible for taking their own medications, e.g. living in a medical care facility
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
This is a randomized controlled intervention trial in poorly compliant patients, testing whether improved compliance behavior decreases rates of acute rejection risk and graft loss.
Hypothesis: A study of an intensive intervention focused on the least compliant patients and beginning 3 months post-transplant. Effective intervention will reduce the number of acute rejection episodes and thus the occurrence of chronic rejection and graft loss.
Read the detailed description
Our original studies demonstrated "early" noncompliant behavior predicted adverse transplantation outcomes including acute graft rejection and graft loss. In this study, we are randomly assigning a telephone intervention in a prospective cohort of medically noncompliant patients. Standard therapy includes specifically warning patients about the risks of noncompliant behavior, and the formal intervention is randomized so half of these patients will also receive intensive telephone followup, intended to improve medication compliance and reduce adverse events.
- Conditions
- Kidney Transplantation
- Being tested
- Intensive telephone followup
- Keywords
- Medication adherence, Patient compliance, Kidney transplant, Organ rejection, Allograft loss, Drug monitoring
- Medical subject headings
- Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive telephone followupBehavioural
Telephone calling
| Study group | Role | What they receive |
|---|---|---|
| Phone calling | Experimental | Phone calling to encourage improved adherence Receives: Behavioral: Intensive telephone followup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft loss
Measured: prospective
Secondary outcomes (2)
Acute rejection
Measured: prospective
Death
Measured: prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startAug 1998
- Primary completionNov 2014
- Study completionDec 2014
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas E Nevins, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148174
- Sponsor's protocol ID
- 9611M11943
- Other IDs
- 2P01DK013083-40A1
- Status last verified
- May 2015
- First submitted
- 2 Sep 2005
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors and Intervention for Noncompliance
- ClinicalTrials.gov ID
- NCT00148174
- Acronym / sponsor ID
- 9611M11943
- Conditions
- Kidney Transplantation
- Keywords
- Medication adherence, Patient compliance, Kidney transplant, Organ rejection, Allograft loss, Drug monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 1998
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 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.
This is a randomized controlled intervention trial in poorly compliant patients, testing whether improved compliance behavior decreases rates of acute rejection risk and graft loss.
Hypothesis: A study of an intensive intervention focused on the least compliant patients and beginning 3 months post-transplant. Effective intervention will reduce the number of acute rejection episodes and thus the occurrence of chronic rejection and graft loss.
Detailed description
Our original studies demonstrated "early" noncompliant behavior predicted adverse transplantation outcomes including acute graft rejection and graft loss. In this study, we are randomly assigning a telephone intervention in a prospective cohort of medically noncompliant patients. Standard therapy includes specifically warning patients about the risks of noncompliant behavior, and the formal intervention is randomized so half of these patients will also receive intensive telephone followup, intended to improve medication compliance and reduce adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phone calling | Experimental | Behavioral: Intensive telephone followupPhone calling to encourage improved adherence |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Kidney transplant
- Discharged from hospital with functioning graft
Key exclusion criteria (10 listed)
- Risk of recurrent primary renal disease, e.g. hemolytic uremic syndrome, oxalosis, membranoproliferative glomerulonephritis type II, focal,segmental glomerulosclerosis with nephrotic syndrome
- Patients with active psychosis
- Patients not using azathioprine, sirolimus, or mycophenolate mofetil for immunosuppression at the time of discharge
- Patients taking the liquid form of azathioprine or mycophenolate mofetil
- Patients who are younger than 14 yrs. old
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 |
|---|---|---|
| Intensive telephone followupTelephone calling | Behavioural | Phone calling |
Primary outcome
Graft loss
Time frame: prospective
2 secondary outcomes
Acute rejection
Time frame: prospective
Death
Time frame: prospective
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 1 Jun 2015.
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Kidney Transplantation
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.
Thomas E Nevins, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive telephone followup in people with Kidney Transplantation, run by University of Minnesota at 1 site in United States.
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 2 inclusion and 10 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 1 Jun 2015. 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 United States. 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?
Graft loss (time frame: prospective). 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 1 Jun 2015.