Kidney TransplantNCT00143910
Natural History Study of Azathioprine Adherence
An observational study of Kidney Transplant, run by Thomas E. Nivens, MD at 1 site in United States.
Trial summary
This study began in 1993 as a prospective, natural history study of renal transplant patients' medication compliance measured by using an electronic monitor on the cap of medication vials. Hypothesis: Poor medication compliance predicts adverse outcomes. Enrollment is closed. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- observation
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1993to Oct 1999
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Successful renal transplant recipients, discharged from hospital with a functioning renal transplant.
Who may be able to join
- Kidney transplant recipient
- Discharged from hospital with functioning graft,not on dialysis
- Prescribed azathioprine
Who cannot join
- Unable to give informed consent
- Non English speaking
- Previous or concurrent organ transplant other than kidney
- Taking liquid form of azathioprine
- Followed outside of the United states
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Measurement of Compliance in Renal Transplant Recipients
This study began in 1993 as a prospective, natural history study of renal transplant patients' medication compliance measured by using an electronic monitor on the cap of medication vials. Hypothesis: Poor medication compliance predicts adverse outcomes. Enrollment is closed.
Read the detailed description
- The study is complete. Patient recruitment is closed and active patient involvement in the study has ended.
- Statistical analysis of monitor records and new patient outcome data continues
- Conditions
- Kidney Transplant
- Being tested
- observation
- 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.
observationOther
| Study group | Role | What they receive |
|---|---|---|
| Renal transplant recipient | Recipients of successful renal transplant Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute transplant rejection
Measured: 10 years
Secondary outcomes (1)
Allograft loss
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startApr 1993
- Primary completionOct 1999
- Study completionOct 1999
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 Kidney TransplantStudies 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
- 180 participants
Sponsor and investigators
- Lead sponsor
- Thomas E. Nivens, MD
- Responsible party
- Sponsor
- Investigators
- Thomas E Nevins, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143910
- Sponsor's protocol ID
- 9109M04306
- Other IDs
- NIH - DK13083
- Status last verified
- Oct 2023
- First submitted
- 1 Sep 2005
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Nevins TE, Kruse L, Skeans MA, Thomas W. The natural history of azathioprine compliance after renal transplantation. Kidney Int. 2001 Oct;60(4):1565-70. doi: 10.1046/j.1523-1755.2001.00961.x.
PubMed 11576374
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Compliance in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT00143910
- Acronym / sponsor ID
- 9109M04306
- Conditions
- Kidney Transplant
- Keywords
- Medication adherence, Patient compliance, Kidney transplant, Organ rejection, Allograft loss, Drug monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Thomas E. Nivens, MD
- Study start
- Apr 1993
- Primary completion
- Oct 1999 (actual)
- Study completion
- Oct 1999 (actual)
- First posted
- 2 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 study began in 1993 as a prospective, natural history study of renal transplant patients' medication compliance measured by using an electronic monitor on the cap of medication vials. Hypothesis: Poor medication compliance predicts adverse outcomes. Enrollment is closed.
Detailed description
- The study is complete. Patient recruitment is closed and active patient involvement in the study has ended.
- Statistical analysis of monitor records and new patient outcome data continues
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal transplant recipient | – | Other: observationRecipients of successful renal transplant |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Successful renal transplant recipients, discharged from hospital with a functioning renal transplant.
Key inclusion criteria (3 listed)
- Kidney transplant recipient
- Discharged from hospital with functioning graft,not on dialysis
- Prescribed azathioprine
Key exclusion criteria (5 listed)
- Unable to give informed consent
- Non English speaking
- Previous or concurrent organ transplant other than kidney
- Taking liquid form of azathioprine
- Followed outside of the United states
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 |
|---|---|---|
| observation | Other | Renal transplant recipient |
Primary outcome
acute transplant rejection
Time frame: 10 years
1 secondary outcome
Allograft loss
Time frame: 10 years
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 4 Oct 2023.
- Results publication: PubMed 11576374Nevins TE, Kruse L, Skeans MA, Thomas W. The natural history of azathioprine compliance after renal transplantation. Kidney Int. 2001 Oct;60(4):1565-70. doi: 10.1046/j.1523-1755.2001.00961.x.
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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.
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?
An observational study of Kidney Transplant, run by Thomas E. Nivens, MD 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 3 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 4 Oct 2023. 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?
acute transplant rejection (time frame: 10 years). 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 NCT00143910, 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 4 Oct 2023.