Accelerated Mortality on Renal Replacement (ArMORR)

July 19, 2007 updated by: Massachusetts General Hospital
The purpose of this study is to prospectively identify blood markers that identify chronic hemodialysis patients at risk for early (<90 days) and late (>= 1 year) mortality

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The annual incidence of patients initiating chronic hemodialysis (HD) will double (~100K→~200K) over the next decade. Despite several advances, HD mortality rates remain extremely high and have not dramatically changed over the past several years. The United States Renal Data System (USRDS) is the largest epidemiological database of patients with end-stage renal disease (ESRD) throughout the US, and studies utilizing the USRDS and similar studies emanating from large dialysis providers have served as the benchmark for guiding the care of all dialysis patients in the US While these databases have been an excellent resource for testing hypotheses, lack of concomitant blood samples has prevented a large-scale clinical trial testing of hypotheses necessitating biological samples. To overcome this limitation, we established a 'USRDS-like' clinical trial with the largest US dialysis provider to prospectively acquire research quality demographic data and concomitant biological samples to test two specific aims:

AIM 1: HD patients are profoundly vitamin D deficient, yet ~60% of incident hemodialysis patients in the US are not treated with active vitamin D. Vitamin D is linked with cardiovascular health, and although higher serum vitamin D levels are associated with improved survival in different settings (e.g., cancer, infection), no large study has examined whether baseline vitamin D levels are associated with HD mortality. Measuring serum vitamin D levels among HD patients is sporadic since the utility of this measurement as it relates to dialysis mortality is unclear.

Hypothesis: Higher vitamin D levels at initiation of HD are associated with lower risk of 90-day and 1-year mortality among patients who do not receive vitamin D therapy.

AIM 2: Among diabetic non-HD patients, blood levels of HbA1c predict all cause and cardiovascular related mortality. Diabetes is the leading cause of ESRD in the US (~50% of all ESRD patients) and mortality rates of diabetics on HD are ~10-20% higher than non-diabetics. Leading Nephrology thought leaders and regulatory bodies (tied to reimbursement and quality control) suggest HbA1c levels must be routinely checked in diabetic HD patients. Importantly, the association between HbA1c levels and all-cause and cardiovascular mortality among HD patients is unclear (in contrast to non-HD data), and erythropoietin therapy and shortened red-cell survival (common in HD patients) render measurements of HbA1c less meaningful.

Hypothesis: Elevated HbA1c levels (among diabetics) at the initiation of HD are associated with increased 90 day mortality, however, HbA1c measurements performed thereafter, e.g., at 90 days following the initiation of HD, are not associated with subsequent 1 year survival.

These aims are examined in a prospective cohort study (of incident HD patients living throughout the US (>1000 centers) with detailed demographic data updated daily, and research quality blood samples collected every 3 months from the initiation of chronic HD. We initiated this "USRDS-like" study to overcome one of the largest limitations of existing epidemiological dialysis datasets - lack of concomitant biological samples in a nationally representative cohort. The study will be available for data sharing and patient protection measures are in place.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10018

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • End stage renal disease on hemodialysis at Fresenius Medical Center
  • New initiation of hemodialysis

Exclusion Criteria:

  • Death with 14 days of initiation of hemodialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pennsylvania
Beth Israel Deaconess Medical Center
Massachusetts Institute of Technology
Cedars-Sinai Medical Center
Harvard University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ravi I Thadhani, MD, MPH, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2003P000373
  • 5R21DK71674-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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