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Protocol Details

The Nephrotic Syndrome Study Network (NEPTUNE)

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

11-DK-0023

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: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Proteinuria;
Focal Segmental Glomerulosclerosis;
Membranous Nephropathy;
Chronic Kidney Disease;
Systems Biology

Recruitment Keyword(s)

Kidney Disease;
Nephrotic Syndrome;
Glomerulonephritis;
Glomerulosclerosis;
FSGS

Condition(s)

Kidney Disease;
Nephrotic Syndrome;
Glomerular Disease;
Glomerulonephritis;
Glomerulosclerosis, Focal

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

Background:

- The Nephrotic Syndrome Study Network (NEPTUNE) is a network of multidisciplinary researchers who are investigating why kidney disease happens. NEPTUNE researchers will collect kidney tissue and other samples (for example, blood and urine) from individuals who are scheduled to have kidney biopsies to determine the cause of protein in the urine (only one kidney biopsy is necessary).

Objectives:

- To collect kidney tissue, other samples, and data /information for continuing research into kidney diseases.

Eligibility:

- Individuals at least 18 years of age who need to have a kidney biopsy to determine the cause of protein in the urine, do not have a systemic disease that is the cause of the their kidney disease, and have not received specific treatment for kidney disease.

Design:

- This study involves a screening and baseline visit and additional followup visits after the kidney biopsy.

- Participants will be screened with a medical history and physical examination, as well as blood and urine samples and collection of fingernail clippings. Participants will also complete questionnaires about their history of kidney problems.

- During the kidney biopsy, performed at the NIH Clinical Center, researchers will take an additional tissue sample for research.

- Participants will return for followup visits at NIH every 4 months in the first year, and every 6 months in the second through fifth years after the biopsy. Additional blood and urine samples will be collected at each visit, and fingernail clippings will also be collected annually by the study researchers.

- Treatment for kidney disease will not be provided as part of this protocol and instead will generally be provided by the patient s own physician.

Compensation:

Subjects received compensation for each visit to the NIH Clinical Center.

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Eligibility

INCLUSION CRITERIA

Inclusion Criteria for the FSGS/MCD Cohort

- A new diagnosis of FSGS or MCD according to characteristic light, electron (EM), and immunofluorescence microscopy (IM), with presence of at least five glomeruli per biopsy available for analysis. Biopsy slides will be reviewed and diagnosis confirmed by 2 study pathologists according to standardized criteria developed by the pathology committee;

- Documented urinary protein excretion greater than or equal to 500 mg/24 hours or spot protein: creatinine ratio equivalent at the time of diagnosis or within 3 months of the screening/eligibility visit.

Inclusion criteria for the MN Cohort

- A new diagnosis of MN according to characteristic light, electron (EM), and immunofluorescence microscopy (IM), with presence of diagnostic changes in at least one glomerulus per biopsy. Biopsy slides will be reviewed and diagnosis confirmed by 2 study pathologists according to standardized criteria developed by the pathology committee

- Documented urinary protein excretion greater than or equal to 500 mg/24 hours or spot protein: creatinine ratio equivalent at the time of diagnosis or within 3 months of the screening/eligibility visit.

Inclusion criteria for the OG Cohort

- A new diagnosis of glomerulopathy according to characteristic light, electron (EM), and immunofluorescence microscopy (IM), with presence of diagnostic changes in at least one glomerulus per biopsy. Biopsy slides will be reviewed and diagnosis confirmed by 2 study pathologists according to standardized criteria developed by the pathology committee;

- Documented urinary protein excretion greater than or equal to 500 mg/24 hours or spot protein:creatinine ratio equivalent at the time of diagnosis or within 3 months of the screening/eligibility visit.

EXCLUSION CRITERIA

Exclusion criteria for the FSGS/MCD and MN Cohorts

-Prior solid organ transplant

- A clinical diagnosis of FSGS/MCD or MN without diagnostic renal biopsy

- Clinical, serological or histological evidence of systemic lupus erythematosus (SLE) as defined by the ARA criteria. Patients with membranous in combination with SLE will be excluded because this entity is well defined within the International Society of Nephrology/Renal Pathology Society categories of lupus nephritis, and frequently overlaps with other classification categories of SLE nephritis

- Clinical or histological evidence of other renal diseases (Alport, Nail Patella, Diabetic Nephropathy, IgA-nephritis, monoclonal gammopathy (multiple myelomas), genito-urinary malformations with vesico-uretheral reflux or renal dysplasia)

- Known systemic disease diagnosis at time of enrollment with life expectancy less than 6 months

- Unwillingness or inability to give a comprehensive informed consent

- Unwillingness to comply with study procedures and visit schedule

- Institutionalized individuals (e.g., prisoners)

- Laboratory information unavailable prior to consent and biopsy procedure subsequently supporting exclusion criteria will deem a participant ineligible.

Exclusion Criteria for the Other Glomerulopathies

- Prior solid organ transplant

- A clinical diagnosis of glomerulopathy without diagnostic renal biopsy

- Clinical, serological or histological evidence of systemic lupus erythematosus (SLE) as defined by the ARA criteria. Patients with membranous in combination with SLE will be excluded because this entity is well defined within the International Society of Nephrology/Renal Pathology Society categories of lupus nephritis, and frequently overlaps with other classification categories of SLE nephritis

- Clinical or histological evidence of other renal diseases (Alport, Nail Patella, Diabetic Nephropathy, IgA-nephritis, monoclonal gammopathy (multiple myelomas), genito-urinary malformations with vesico-uretheral reflux or renal dysplasia)

- Known systemic disease diagnosis at time of enrollment with a life expectancy less than 6 months

Unwillingness or inability to give a comprehensive informed consent

- Unwillingness to comply with study procedures and visit schedule

- Institutionalized individuals (e.g., prisoners)

- Laboratory information unavailable prior to consent and biopsy procedure subsequently supporting exclusion criteria will deem a participant ineligible.


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Citations:

Ellis EN, Martz K, Talley L, Ilyas M, Pennington KL, Blaszak RT. Factors related to long-term renal transplant function in children. Pediatr Nephrol. 2008 Jul;23(7):1149-55. Epub 2008 Feb 27.

Schnaper HW. Primary nephrotic syndrome of childhood. Curr Opin Pediatr. 1996 Apr;8(2):141-7.

Tune BM, Mendoza SA. Treatment of the idiopathic nephrotic syndrome: regimens and outcomes in children and adults. J Am Soc Nephrol. 1997 May;8(5):824-32.

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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)
BG 10 RM 3N114
10 CENTER DR
BETHESDA MD 20814
(301) 594-3403
jeffreyk@mail.nih.gov

Jeffrey B. Kopp, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 3N114
10 CENTER DR
BETHESDA MD 20814
(301) 594-3403
jeffreyk@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

Clinical Trials Number:

NCT01209000

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