Glomerulonephritis after COVID-19 vaccination

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Thank you for agreeing to contribute to the I-RocGN2 Registry. It is designed to investigate and better understand new onset glomerulonephritis after COVID-19 vaccination or relapses of glomerulonephritis that occurred after vaccination. This does not imply a causal relationship.

This survey is to be completed by a health care professional caring for the affected individual

If you have any questions, please reach out to: niddkcovidgn@niddk.nih.gov

Thank you!

On Behalf of the IrocGN2 Consortium

Meryl Waldman, MD National Institute of Health, NIDDK, Kidney Disease Branch, Bethesda, MD

Tiffany Caza MD, PhD Arkana Labs, Little Rock, AR

Edgar V. Lerma MD Clinical Professor of Medicine, Section of Nephrology, University of Illinois at Chicago College of Medicine/ Advocate Christ Medical Center

Name of Reporter

Email address of reporter

Subject ID :

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Name of Institution or Practice Providing Care

Country

Age of Patient

Gender

Race

Ethnicity

Did this patient develop new onset glomerulonephritis after receiving SARs-Cov2 vaccination?

Yes

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Did the patient experience RELAPSE of their known glomerulonephritis after COVID vaccination

Yes

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Did GN occur in native kidney or transplanted kidney?

Did GN occur after the Primary Vaccination series or after Booster?

Primary vaccination

booster

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What was date of Renal biopsy ?

M-D-Y

Which COVID-19 vaccine(s) did the patient receive?

Pfizer-BioNTech

Moderna

J&J/Janssen

Oxford/AstraZeneca

Sinopharm/Beijing

Sinovac

Sputnik V

Covaxin

CanSino

other

Did the patient receive one dose of a vaccine or two doses?

one

two

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Please enter the date of Vaccine Dose 1

M-D-Y

Please enter the date of Vaccine Dose 2

M-D-Y

Did the patient receive Booster doses after the primary Vaccine series?

Yes

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Please enter the date of the Booster dose #1

M-D-Y

Please enter the date of Booster dose #2
(leave blank if not received)

M-D-Y

Did GN diagnosis occur after the 1st dose or 2nd dose (of 2 dose series) or after the boosters?

after 1st dose

after 2nd dose

after Booster 1

after Booster 2

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Elapsed Time from Vaccine dose #1 to Date of Renal biopsy

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Elapsed time from Vaccine dose #2 to Date of Renal biopsy

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Elapsed Time from Booster dose #1 to Date of Renal biopsy

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Elapsed Time from Booster dose #2 to Date of Renal biopsy

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Elapsed time from last shot to renal biopsy

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Was the 2nd dose of vaccine or another vaccine adminstered if the patient had new onset GN after 1st dose of vaccine?

NO, the 2nd dose of series was WITHHELD

Yes, the 2nd dose of series was given without delay in recommended schedule

Yes, the 2nd dose was given but with timing delayed

A different vaccine was given

decision has been deferred

What histology was seen on the Renal Biopsy?

Minimal change disease

Focal segmental glomerulosclerosis

collapsing glomerulopathy

Membranous nephropathy

Lupus Nephritis

Vasculitis

Anti -GBM disease

C3 glomerulopathy

Membranoproliferative glomerulonephritis NOS

Thrombotic microangiopathy

IgA Nephropathy

pauci-immune crescentic GN

Deposition disease NOS

fibrillary GN

immunotactoid GN

MIDD

amyloid AL

amyloid AA

Post infectious Glomerulonephritis

Other

global glomerulosclerosis

chronic tubulointerstitial nephritis

mesangial proliferative glomerulonephritis (non-IgAN)

For this MN case, please specify positive Tissue staining/ expression of antigens on renal biopsies

M-type phospholipase A2 receptor (PLA2R),

thrombospondin type-1 domain-containing 7A (THSD7A)

neural epidermal growth factor-like 1 protein (NELL-1)

Exotosin 1 (EXT1)- and exotosin 2 (EXT2)

Sema3B

PCDH7

NEGATIVE , no antigens detected

no staining was performed to detect these antigens

Please select features present on Renal biopsy
(choose all that apply)

collapsing features

crescents

vascular thrombosis

tubular reticular inclusions (TRI)

focal acute tubular injury

diffuse acute tubular injury

acute tubular necrosis

tubulointerstitial nephritis/inflammatory infiltrate

"Virally infected cells"/viral inclusions

microangiopathic changes

subepithelial deposits

mesangial deposits

endocapillary proliferation

subendothelial deposits

subepithelial humps

none were present

global sclerosis

inflammatory infiltrate

moderate/severe interstitial fibrosis, tubular atrophy

mild-moderate interstitial fibrosis, tubular atrophy

IgA staining

Was genotyping for APOL1 risk alleles performed?

Yes

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What were results of APOL1 genotyping?

0 APOL1 risk allele

1 APOL1 risk allele

2 APOL1 risk alleles (high risk)

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Please select relevant positive serologies that were related to new onset GN
(choose all that apply)

ANA

dsDNA

ENA

SSA

SSB

p-ANCA

c-ANCA

anti MPO

anti PR3

anti-GBM (glomerular Basement membrane)

C3 (low)

C4 (low)

Anti -PLA2R

Anti-THSDA

C3 nephritic factor

C5b-9

other testing

none are relevant for this glomerular disease

Was the patient checked for the presence of Antibodies to SARC-CoV2 spike protein after vaccination?

Yes

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Was the spike protein present?

Yes

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Did the patient develop any of the following signs or symptoms of renal disease after COVID-19 vaccination ?
(choose all that apply)

foamy urine

macroscopic hematuria

microscopic hematuria

swelling/ edema

hypertension

pulmonary edema, congestive heart failure

none of these were present

Approximately how long after COVID vaccine administration did renal-related symptoms appear?

within hours

with 1-2 days

within 3-4 days

within 5-7 days

2 weeks

3 weeks

4 weeks

5 weeks

6 weeks

7 weeks

8 weeks

3 months

NOT SURE

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Did the patient develop other (non-renal) symptoms or problems after COVID vaccine?
(choose all that apply)

fever

fatigue

nausea

rash

muscle ache

dizziness, vertigo

shortness of breath

chest pain

tinnitus

thrombotic event

pericarditis/myocarditis

neuropathy

weakness

joint pain, arthritis

thrombocytopenia

Guillain-Barré syndrome

stroke

cerebral venous sinus thrombosis

none of the above

other

pulmonary hemorrhage

Check any underlying conditions that the patient had prior to Vaccine
(choose all that apply)

Hypertension

Diabetes

Chronic kidney disease

Coronary artery disease

congestive heart failure

Asthma or COPD

Lupus

Rheumatoid arthritis

Vasculitis

other systemic autoimmune condition

Cancer

Transplant (bone marrow or solid organ excluding renal transplant)

Renal transplant

HIV / AIDS

Obesity

inflammatory bowel disease

Chronic liver disease (NAFLD, cirrhosis)

hepatitis B or C

hypercoagulable state, history of clots (PE, DVT)

neurologic disorder (ie parkinsons, multiple sclerosis)

History of stroke

Current Smoker

other

What other systemic autoimmune condition did the patient have?

What other medical condition did the patient have before vaccination ?

Did the patient have known history of COVID-19 infection prior to getting the COVID vaccine?

Yes

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If known, please enter the date of diagnosis of previous COVID-19 infection

M-D-Y

Elapsed time from COVID infection to Vaccination

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Did the patient have a prior history of reactions to OTHER vaccines (besides COVID vaccine)?

Yes

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What reactions did the patient have to previous vaccines?

anaphylaxis

rash

fever

autoimmune disease new onset

autoimmune disease, flare

clot

neurologic issues, stroke, neuropathy

liver dysfunction

headaches

vertigo

joint pain, myalgias

Baseline labs BEFORE vaccination

Please enter the data below for this patient's baseline (prior to vaccination) labs.

Enter directly into table

Lab Date	Serum Creatinine (mg/dl)	eGFR	Proteinuria (g/g)	Serum Albumin (g/dl)

Labs AFTER Vaccination at (around) time of GN diagnosis/Renal Biopsy

Please enter the labs data available after vaccination at (or around) time of Renal biopsy

Enter directly into table

Lab Date	Serum Creatinine (mg/dl)	eGFR	Proteinuria (g/g)	Serum Albumin (g/dl)

Follow up labs AFTER GN diagnosis

Please enter follow up lab data after GN diagnosis

Enter directly into table

Lab Date	Time Elasped from renal biopsy to labs	Serum Creatinine (mg/dl)	eGFR	Proteinuria (g/g)	Serum Albumin (g/dl)








Lab Date	Time Elasped from renal biopsy to labs	Serum Creatinine (mg/dl)	eGFR	Proteinuria (g/g)	Serum Albumin (g/dl)

How was GN managed?
(choose all that apply)

conservative, observation only

RAAS inhibition

immunosuppression

other

If conservative management, did the GN improve spontaneously?

Yes

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Please select immunosuppressive treatments provided for new onset GN after Vaccine
(check all that apply)

steroids

mycophenolate mofetil or mycophenolic acid

azathioprine

tacrolimus

cyclosporine

sirolimus

rituximab

other anti CD20

cytoxan

plasma exchange

IVIG

anti CD38

methotrexate

ACTHAR

belimumab

eculizumab or other anti complement therapy

other

Please provide more details on the regimen of steroids used such as:

-corticosteroid preparation(s)

-oral and/or IV

   -dosage/day
   -duration of steroids
   -Taper

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Please provide details of the dosage and duration including
-preparation (CellCept vs Myfortic)
-dosage
-duration

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Please provide any details of the dosage of Tacrolimus used including
-dose
-duration

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Please provide more details on regimen of rituximab used including
-dose (ie 375 mg/m2, 500 mg, 1 gram)
-frequency (ie weekly x4, 2 doses on Day 1, 15, single dose)
-number of cycles given
-timing between cycles (ie 6 months)

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What other immunosuppression was provided?

Date of most recent follow up

M-D-Y

Time elapsed from Renal Biopsy to most recent follow up

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At most recent follow up, please selection option that best describes status of kidney disease

spontaneous remission

partial remission WITHOUT treatment

partial remission after treatment

complete remission after treatment

no response to treatment/no remission

progression of disease with decline in GFR

persistent proteinuria

pt relapsed after achieving remission

progression to ESKD requiring renal replacement therapy

patient died

How would you best characterize timing of the patient relapse?
choose all that apply

occurred after receiving another dose of vaccine or booster (the SAME as primary series)

occurred after receiving a different COVID vaccine or booster

occurred after stopping immunosuppression

occurerd after COVID-19 infection that occurred despite vaccination

none of above, unable to determine any trigger for the relapse

AT most recent follow up, what is best characterization of the relevant serologies related to the GN?

normalized, negative

improved but still abnormal

worsened

not sure, Not available

What is the value for the ANA at the time of renal biopsy?

Serologies relevant to the glomerulenephritis

Please enter Serial Labs, if availiable durectly into table


ANA
dsDNA
ENA
SS-A(Ro)
SS-B(La)
C3
C4
P-ANCA
C-ANCA
Anti PR3
Anti MPO
Anti GBM
Anti PLA2R
Anti THSD7a

Did the patient receive any other vaccines within 3 months (before or after) of the COVID vaccine?

Yes

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Which vaccine(s) did the patient receive ?
(choose all that apply)

influenza

HPV

pneumococcal

MMR

Tdap vaccine

Tetanus

hepatitis B

hepatitis A

polio

varicella

meningococcal

zoster

other

What was the date of administration of other vaccine(s) that was closest in timing to the COVID vaccine?

M-D-Y

Do you have any comments that would provide further insight into this patient's diagnosis or course?

(please include any other confounding factors that might have contributed to new onset GN. i.e NSAID use, hydralazine, other drugs or therapies, other infections/exposures)

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