A Study of Factors That Affect Long-Term Kidney Transplant Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The causes of deterioration of transplanted kidney function are poorly understood. The purpose of this study is to determine the disease processes that cause transplanted kidney dysfunction and loss in patients who received a kidney either recently or over a year prior to entering this study. This study will also identify specific characteristics in kidney transplant recipients that predict whether a kidney transplant will be successful.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Study of Long-term Deterioration of Kidney Transplants.

NCT00217126

Kidney Transplant

COMPLETED

Long-term Cardiovascular Risk Following Successful Renal Transplantation

NCT01728012

Renal Transplant

COMPLETED

Identification of Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais , Normandy and Picardy Regions

NCT02121730

Cancer of Kidney

UNKNOWN

The Role of Connective Tissue Growth Factor in the Development of Kidney Disease After Organ Transplantation

NCT00056784

Kidney Transplantation

COMPLETED

Multimorbidity and Cardiovascular Risk Factors After Renal Transplant

NCT07205692

Kidney Transplant Cardiovascular (CV) Risk Multimorbidity

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Over time, chronic kidney graft dysfunction progressively threatens the long-term survival of a kidney graft. The disease processes behind graft dysfunction are unclear. However, chronic kidney graft dysfunction is likely to be caused by certain definable factors. Such factors may include collagens III and IV, transforming growth factor (TGF)-beta, T and B cell surface markers, cell cycle proteins, fibronectin, and laminin. Determining what disease processes and which specific factors are most responsible for kidney graft dysfunction may help in designing future interventional trials for kidney transplant patients. The purpose of this study is to determine whether clinical, laboratory, and histologic studies at the time of initial graft dysfunction will clarify the processes and factors that lead to deterioration and loss of a kidney graft. This is an observational study that will enroll participants who have recently received kidney transplants (prospective cohort) and participants who have had kidney transplants for a longer period of time and are now experiencing kidney graft dysfunction (retrospective cohort).

The duration of this trial may differ between participants, depending on when deterioration of kidney graft function occurs. Participants will be followed until graft loss or death. There are no exclusive study visits associated with this study. Study data are gathered from routine laboratory follow-up tests completed at the participant's local medical center and from information obtained at the time of kidney biopsy. Participants may need to undergo a kidney biopsy as clinically indicated. At the time of biopsy, participants will also undergo urine and blood collection.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Transplant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Retrospective Cohort

537 transplant recipient records used retrospectively

No interventions assigned to this group

Prospective Cohort

3137 transplant recipients enrolled prospectively

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Received a kidney transplant within 10 days prior to study entry, on or after 10-01-2005
* Recipient of kidney or simultaneous kidney/pancreas with no additional transplant at the time of the kidney transplant

* Received a kidney transplant before 10-01-2005
* Recipient of kidney or simultaneous kidney/pancreas with no additional transplant at the time of the kidney transplant
* Undergoes a clinically indicated kidney biopsy due to new onset deterioration of function, defined as having an increase in serum creatinine
* The creatinine level on or before 01-01-2006 must be 2 mg/dl or less OR the patient must have developed new onset proteinuria, defined as having a protein/creatinine ratio of 0.4 or more

Eligible Sex

ALL

Accepts Healthy Volunteers

No