Resources for clinicians
Find eligibility criteria and resources for each NEPTUNE study cohort, and NEPTUNE Match.
NEPTUNE clinical cohorts - Eligibility
NEPTUNE enrolls participants into three longitudinal cohorts: biopsy, non-biopsy, and Alport syndrome cohorts. Participants provide blood, urine, and clinical data at enrollment and at 4-6 month intervals. Visits are in-person and by telephone.
Learn more about the NEPTUNE study by referencing our NEPTUNE Overview Slide Deck. Information on the cohorts is also summarized in our One-page Cohort Overview. To aid in determining participant eligibility, reference our Enrollment Triage Chart.
Participants eligible for and interested in NEPTUNE Match are also eligible for enrollment into the NEPTUNE study. The eligibility criteria for NEPTUNE Match are dynamic and will change as new trials are added.
Biopsy cohort
Adults and children with biopsy-proven FSGS, MCD, or MN, are recruited at the time of biopsy and followed for 36 months. Participants may be enrolled at their first clinically indicated renal biopsy if diagnosis is expected to be FSGS, MCD, or MN. Participants will be disenrolled if other diagnoses are determined. Alternatively, adults and children with a prior biopsy confirming FSGS, MCD or MN are recruited at the time of a follow-up or subsequent biopsy for the NEPTUNE prevalent cohort.
Inclusion criteria
Incident
- First known clinically indicated renal biopsy
- Consent to an additional renal biopsy core, to be set aside until all clinical care is complete
- > 1500mg/24hrs proteinuria or spot UPC equivalent
(1.5 g/g UPCR) - < 80 years of age
- Completion of baseline visit within 60 days of biopsy visit
Prevalent
- Prior confirmatory renal biopsy indicating FSGS, MCD, or MN
- Consent to an additional renal biopsy core, to be set aside until all clinical care is complete
- < 80 years of age
- Completion of baseline visit within 60 days of biopsy visit
Exclusion criteria
- Evidence of other renal disease
(e.g. lupus, diabetic nephropathy, myeloma, reflux) - Prior solid organ transplant
- Life expectancy < 6 months
Visit schedule
(phone)
(phone)
(phone)
Non-biopsy cohort
Participants under 19 years of age, with < 30 days exposure to immunosuppression therapy who are not scheduled for renal biopsy. Participants are followed for up to 10 years with each year having one phone visit and one in-person visit.
Inclusion criteria
Proteinuria/Nephrotic defined as:
- Urinalysis with >2+ protein AND edema OR
- Urinalysis with >2+ protein AND serum albumin < 3 OR
- Urine protein:creatinine ratio (UPCR) >2 AND serum albumin OR
- Urine protein:creatinine ratio (UPCR) >2 AND edema
Exclusion criteria
- End Stage Kidney Disease (ESKD)
- Prior solid organ or bone marrow transplant
- Secondary NS (systemic lupus erythematosus (SLE), vasculitis, Henoch Schonlein Purpura, Hepatitis B, C or HIV nephropathy)
- Other renal diseases (Alport syndrome, Nail Patella syndrome, Diabetic Nephropathy, monoclonal gammopathy (multiple myelomas), genito-urinary malformations with vesico-uretheral reflux or renal dysplasia)
- Known systemic disease diagnosis with life expectancy less than 6 months
Visit schedule
(phone)
(phone)
(phone)
Alport syndrome cohort
Children of all ages or adults < 80 years old with a clinical indication for Alport syndrome. May be recruited at the time of biopsy. Biopsy is not required for participation in this study.
Inclusion criteria
Participants must have at least one of the following:
- Prior confirmatory biopsy or a genetic test result that identifies Alport syndrome, OR
- Hematuria or proteinuria & hearing loss, OR
- Familial history of Alport syndrome
Exclusion criteria
- End Stage Kidney Disease (ESKD)
- Prior solid organ transplant
- Evidence of other renal disease (e.g. lupus, diabetic nephropathy, myeloma, reflux)
- Life expectancy < 6 months
Visit schedule
(if applicable)
(phone)
(phone)
(phone)
Study participant support for Alport syndrome cohort
Alport Syndrome Foundation, the non-profit patient support group sponsoring this study, is offering small stipends to help offset any out-of-pocket costs, such as travel, for Alport patients participating in the study.
Patients enrolling in the study, or considering enrollment, should contact Alport Syndrome Foundation by clicking the button below. This information will remain confidential between the organization and the patient/caregiver.
NEPTUNE Match
NEPTUNE Match is an additional opportunity offered to NEPTUNE study participants that gives information about which clinical trials may be a match for them by using their individual research data and samples collected from the NEPTUNE study. Any patient who is interested and eligible for NEPTUNE Match may be enrolled into the NEPTUNE study without a new biopsy.
Match eligibility criteria are dynamic and are expected to change as new trials are added. Please refer to the NEPTUNE Match Eligibility Calculator to see if your patient may be eligible.
To learn more, reference our NEPTUNE Match slide deck and Match Brochure.
We are currently matching to the following partnered clinical trials in NEPTUNE Match:
- JUSTICE
A double-blinded, randomized trial of baricitinib therapy for APOL1-associated focal segmental glomerular sclerosis (FSGS) or Hypertension Associated-CKD
- TRPC6 Inhibition in FSGS
Randomized, double-blind study to investigate the efficacy, safety, and tolerability of BI764198 vs placebo in focal segmental glomerular sclerosis (FSGS).
- EPPIK
Open label clinical trial of Sparsentan to evaluate safety and efficacy on proteinuria and kidney function in children with focal segmental glomerular sclerosis (FSGS), minimal change disease, IgAN, IgAV, and Alport syndrome.
- TNF Precision Medicine
A proof of concept, open label clinical trial addressing the treatment of patients with focal segmental glomerular sclerosis (FSGS) or treatment resistant minimal change disease.