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Massive kidney study aims to uncover hidden heart risks

NCT ID NCT00304148

Knowledge-focused Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This long-term study follows over 5,000 people with chronic kidney disease to learn how the condition affects the heart and blood vessels. Researchers are tracking kidney function, heart events like heart attacks and strokes, and various risk factors. The goal is to find better ways to predict and prevent complications in people with kidney disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could identify key risk factors and early markers for kidney disease progression and heart problems, guiding future prevention and treatment strategies.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new therapy. Results may take years to translate into practical medical advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 5,499 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2003

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

In Phase I of the CRIC Study a total of 3,939 individuals across the spectrum of severity of kidney disease were enrolled to ensure that a sufficient number of patients reach the primary study endpoints of kidney disease progression and cardiovascular events. During CRIC Phase III, an additional 1,560 older participants with milder severity of kidney disease were recruited. The 1,560 new cohort members, compared with participants recruited in Phase I, have higher ranges of age and more preserved kidney function, and most have proteinuria. The population of 1560 new recruits have similar characteristics as the current CRIC cohort: \~50% with Diabetes, \~50% female, \~45% white and \~45% African-American.

Ages

21 to 79 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: During the screening visit a blood sample will be tested to indirectly check kidney function based on the serum creatinine level: * Age Range: 21 - 79 years * Estimated Glomerular Filtration Rate (GFR): 45 - 70 mL/min/1.73m² * Proteinuria: varies dependent on eGRF Exclusion Criteria: * Unable or unwilling to provide informed consent * Previously received dialysis (peritoneal and/or hemodialysis) lasting more than one month * Prior organ or bone marrow transplant * Prior renal transplant * Received immunosuppressive or other immunotherapy for primary renal disease or systemic vasculitis that affects the kidneys (i.e., anti-GCM, ANCA, SLE, IgA nephropathy, cryoglobulin, etc.) within the past six months before enrollment * Received chemotherapy or alkylating agents for systemic cancer * Known cirrhosis * NYHA Class III or IV heart failure at baseline * Previous diagnosis of multiple myeloma or renal carcinoma * Previously diagnosed polycystic kidney disease * Known HIV infection and/or AIDS * Pregnant or breast-feeding women * Currently participating in an interventional clinical trial (i.e., primarily trials of therapeutic agents that may have an effect on renal or cardiovascular outcomes). * Institutionalized (e.g., prisoner, nursing home resident, skilled nursing facility resident) * Appears unlikely or unable to participate in the required study procedures as assessed by the investigator, study coordinator or designee.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Renal insufficiency, chronic

Contacts and locations

Locations

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Johns Hopkins Medical Institutions

    Baltimore, Maryland, 21205, United States

  • Kaiser Permanente of Northern California

    Oakland, California, 94612, United States

  • Metrohealth Medical Center

    Cleveland, Ohio, 44109, United States

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112, United States

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106, United States

  • University of California

    San Francisco, California, 94143-0532, United States

  • University of Illinois at Chicago

    Chicago, Illinois, 60612, United States

  • University of Maryland Medical System

    Baltimore, Maryland, 21201, United States

  • University of Michigan Hospitals

    Ann Arbor, Michigan, 48106, United States

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • Wayne State - Harper University Hospital

    Detroit, Michigan, 48201, United States

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