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Protocol Details

Study Glomerulopathy

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-DK-0075

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 0
Max Age: 99

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

IgA Nephropathy;
Proteinuria;
Nephrotic Syndrome;
Focal Segmental Glomerulosclerosis;
Minimal Change Disease

Recruitment Keyword(s)

None

Condition(s)

Glomerular Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

Objective:

To better understand glomerular disease by studying their causes and markers, and by identifying and evaluating new therapies.

Eligibility:

People of all ages who have had a kidney biopsy in the past 5 years and have one of the following glomerular diseases:

Minimal change disease

Focal segmental glomerulosclerosis

Membranous nephropathy

IgA nephropathy

Design:

Participants will give data, such as name, age, race, Social Security number, contact information, and family health history.

Participants doctors will provide pathology slides and a pathology report of their kidney biopsy.

Participants will have at least 1 visit per year for 4 years. They will:

Provide health data from their medical record. These include lab test results, procedures, and medicines.

Fill out forms about how are they are feeling and how their kidney disease affects their lives.

Give blood and urine samples.

Two other visits each year can be done in person or by phone or email. For phone or email visits, participants will be asked if their medicines have changed and if they have symptoms. They will be asked about any remissions or relapses since their last visit.

Researchers may ask to study the participant s genes. A small amount of the blood and urine specimens may be used to create a cell line. This will allow markers of kidney disease to be studied.

Participants will be followed until death, withdrawal of consent, or the end of the study.

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Eligibility

INCLUSION CRITERIA:

-All ages

- Kidney biopsy within 5 years of study enrollment

- Diagnosis of minimal change disease, FSGS, membranous nephropathy, or IgA nephropathy

EXCLUSION CRITERIA:

- End stage kidney disease, defined as chronic dialysis or kidney transplant

- Solid organ or bone marrow transplant recipient at time of first kidney biopsy

- Diagnosis of any of the following:

--Diabetes mellitus

--Systemic lupus erythematosus

--HIV infection

--Active malignancy, except for non-melanoma skin cancer

--Active Hepatitis B or C infection, defined as positive viral load


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Jeffrey B. Kopp, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)



Sheila M. Smith, R.N.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 5-1604
10 Center Drive
Bethesda, Maryland 20892
(301) 451-1180
smiths2@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

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