Section 1 of 1
Real World Outcome of Eculizumab in Post-Kidney Transplant TMA
Kindly fill out a separate Google Form/link for each patient
Kindly fill out a separate Google Form/link for each patient
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A. Center and respondent details
A. Center and respondent details
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1. Name of transplant center
1. Name of transplant center
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2. City/state/country
2. City/state/country
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City
City
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State
State
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Country
Country
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3. Type of Center
3. Type of Center
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Government
Private
Trust
Academic
Other:
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4. Annual Kidney Transplant Volume
4. Annual Kidney Transplant Volume
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5. Respondent Name/Designation
5. Respondent Name/Designation
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6. Contact - Email ID
6. Contact - Email ID
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7.
Contact - Mobile Number
7.
Contact - Mobile Number
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8. Does your center maintain a transplant TMA registry?
8. Does your center maintain a transplant TMA registry?
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B. Incidence and Prevalence
B. Incidence and Prevalence
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1. Total
kidney transplants performed in last 5 years:
1. Total
kidney transplants performed in last 5 years:
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2. Number of suspected post-transplant TMA cases:
2. Number of suspected post-transplant TMA cases:
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3. Number
of biopsy-proven TMA cases:
3. Number
of biopsy-proven TMA cases:
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4. Number of systemic TMA cases:
4. Number of systemic TMA cases:
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5. Number of kidney-limited TMA cases:
5. Number of kidney-limited TMA cases:
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6. Timing of TMA after transplant:
6. Timing of TMA after transplant:
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7 days
7–30 days
1–3 months
3–6 months
> 6 months
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7. Classification:
7. Classification:
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Recurrent aHUS/TMA
De novo post-transplant TMA
Uncertain
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C. Recipient and Transplant Details
C. Recipient and Transplant Details
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1. Recipient Age
1. Recipient Age
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2. Recipient Gender
2. Recipient Gender
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Male
Female
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3. Native Kidney Disease
3. Native Kidney Disease
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4. History
of TMA/aHUS before Transplant
4. History
of TMA/aHUS before Transplant
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No
Unknown
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5. Previous Graft Loss due to TMA
5. Previous Graft Loss due to TMA
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6. Donor Type
6. Donor Type
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Living Related
Living Unrelated
Deceased
ABO-incompatible
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7. HLA Mismatch
7. HLA Mismatch
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8. DSA
present Pre-Transplant
8. DSA
present Pre-Transplant
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9. Induction Used
9. Induction Used
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Basiliximab
ATG
Alemtuzumab
None
Other
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10. Maintenance Immunosuppression
10. Maintenance Immunosuppression
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Tacrolimus
Cyclosporine
mTOR inhibitor
MMF/MPA
Steroids
Belatacept
Other
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11. CNI/mTOR trough level at TMA diagnosis
11. CNI/mTOR trough level at TMA diagnosis
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D.
Clinical presentation
D.
Clinical presentation
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1. Presentation
1. Presentation
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Graft dysfunction
Oliguria
Hypertension/Worsening BP
Proteinuria
Anemia
Thrombocytopenia
GI Symptoms
Cardiovascular Symptoms
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2. Serum Creatinine at Diagnosis
2. Serum Creatinine at Diagnosis
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3. Urine
protein/Creatinine ratio
3. Urine
protein/Creatinine ratio
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4. BP
at Diagnosis
4. BP
at Diagnosis
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5. Need
for Dialysis
5. Need
for Dialysis
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E. Laboratory Diagnosis
E. Laboratory Diagnosis
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1. Hemoglobin
1. Hemoglobin
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2. Platelet Count
2. Platelet Count
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3. LDH
3. LDH
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4. Haptoglobin
4. Haptoglobin
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5. Reticulocyte Count
5. Reticulocyte Count
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6.
Schistocytes
on Peripheral Smear
6.
Schistocytes
on Peripheral Smear
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7. Direct
Coombs test
7. Direct
Coombs test
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8.
C3
8.
C3
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9. C4
9. C4
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10. ADAMTS13
activity tested
10. ADAMTS13
activity tested
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IF YES:
RESULT
RESULT
IF YES:
RESULT
RESULT
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11. STEC/Shiga
toxin testing done
11. STEC/Shiga
toxin testing done
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IF YES:
RESULT
RESULT
IF YES:
RESULT
RESULT
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12. Other Infection Identified
12. Other Infection Identified
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13. Anti-factor
H Antibody Tested
13. Anti-factor
H Antibody Tested
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IF YES:
RESULT
RESULT
IF YES:
RESULT
RESULT
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14. Complement Genetic Testing Done
14. Complement Genetic Testing Done
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IF YES:
IF YES:
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CFH
CFI
C3
CFB
CD46
CFHR
DGKE
THBD
ADAMTS13
Other:
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15. Variant
classification
15. Variant
classification
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Pathogenic
Likely pathogenic
VUS
Negative
Not Available
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F.
Biopsy and Rejection Assessment
F.
Biopsy and Rejection Assessment
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1. Graft Biopsy Performed
1. Graft Biopsy Performed
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2. Biopsy
timing from TMA Suspicion
2. Biopsy
timing from TMA Suspicion
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3. Biopsy
findings:
3. Biopsy
findings:
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Glomerular Thrombi
Arteriolar Thrombi
Endothelial Swelling
Mesangiolysis
Fibrinoid Necrosis
Cortical Necrosis
Chronic TMA Lesions
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4. C4d
staining
4. C4d
staining
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Not done
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5. Microvascular Inflammation
5. Microvascular Inflammation
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6. DSA
at Diagnosis
6. DSA
at Diagnosis
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7. ABMR Diagnosed
7. ABMR Diagnosed
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8. TCMR
present
8. TCMR
present
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9. Electron Microscopy Done
9. Electron Microscopy Done
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10. Final
biopsy impression
10. Final
biopsy impression
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G.
Suspected trigger
G.
Suspected trigger
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1. Most
likely trigger
1. Most
likely trigger
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Recurrent aHUS
ABMR
High CNI level
mTOR inhibitor
CMV
BK virus
Other infection
Ischemia-reperfusion Injury
ABO-Incompatible Transplant
Malignant Hypertension
Autoimmune Disease
Drug-Induced
Unknown/multifactorial
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2. Was
more than one trigger present?
2. Was
more than one trigger present?
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H.
Treatment details
H.
Treatment details
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1. Initial Management
1. Initial Management
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CNI Dose Reduction
CNI Withdrawal
mTOR Withdrawal
Switch to Belatacept
Plasma Exchange
IVIG
Steroids
Rituximab
ABMR Therapy
Antiviral/antibiotic therapy
Supportive care only
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2.
Was Eculizumab Used?
2.
Was Eculizumab Used?
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3. Indication
for Eculizumab
3. Indication
for Eculizumab
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Prophylaxis for recurrent aHUS
Treatment of recurrent TMA
Treatment of de novo TMA
Rescue After Failure of Conventional Treatment
Severe Systemic TMA
Kidney-limited biopsy-proven TMA
ABMR not Responding to Conventional Treatment
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4. Time
from Diagnosis to First Eculizumab Dose
4. Time
from Diagnosis to First Eculizumab Dose
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<24 hours
1–3 days
4–7 days
> 7 days
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5. Eculizumab
Dosing Schedule Used
5. Eculizumab
Dosing Schedule Used
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6. Number
of Doses
6. Number
of Doses
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7. Duration
of Therapy
7. Duration
of Therapy
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8. Was Ravulizumab Used Later?
8. Was Ravulizumab Used Later?
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9. Reason
for stopping eculizumab
9. Reason
for stopping eculizumab
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Completed protocol
Cost
Infection
No Response
Graft Loss
Ongoing Therapy
Achieved remission
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10. Vaccination
before Eculizumab
10. Vaccination
before Eculizumab
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Meningococcal
Pneumococcal
H. Influenzae
Not done
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11. Antibiotic
prophylaxis given?
11. Antibiotic
prophylaxis given?
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12. Funding
source
12. Funding
source
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Self-pay
Insurance
Government Scheme
Hospital Support
Company Access Program
Other:
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I.
Outcomes
I.
Outcomes
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1. Hematological Response
1. Hematological Response
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Complete
Partial
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2. Platelet Recovery Day
2. Platelet Recovery Day
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3.
LDH Normalization Day
3.
LDH Normalization Day
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4.
Creatinine
at 1 Month
4.
Creatinine
at 1 Month
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5.
Creatinine
at 3 Months
5.
Creatinine
at 3 Months
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6.
Creatinine
at 6 Months
6.
Creatinine
at 6 Months
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7.
Creatinine
at 12 Months
7.
Creatinine
at 12 Months
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8.
Dialysis Discontinued?
8.
Dialysis Discontinued?
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9.
Graft Outcome
9.
Graft Outcome
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Functioning Graft
Partial Recovery
Graft loss
Patient Death
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10.
TMA Recurrence after Treatment Withdrawal
10.
TMA Recurrence after Treatment Withdrawal
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11.
Infection
after Eculizumab
11.
Infection
after Eculizumab
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If Yes
Kindly name the infection
Kindly name the infection
If Yes
Kindly name the infection
Kindly name the infection
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12.
Other Adverse Events
12.
Other Adverse Events
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13.
Mortality
13.
Mortality
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J.
Real-world Barriers and Opinion
J.
Real-world Barriers and Opinion
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1.
Main Barriers to Eculizumab Use
1.
Main Barriers to Eculizumab Use
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Cost
Availability
Diagnostic Uncertainty
Delay in Approval
Vaccination Concerns
Infection Risk
Lack of Protocol
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2. In which Cases would you Consider Eculizumab?
2. In which Cases would you Consider Eculizumab?
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Recurrent aHUS only
Severe de novo TMA
Biopsy-proven kidney-limited TMA
TMA refractory to CNI withdrawal/ABMR treatment
All complement-mediated cases
ABMR not responding to conventional Treatment
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3. Do you support Creating a National Post-Transplant TMA Registry?
3. Do you support Creating a National Post-Transplant TMA Registry?
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4.
Are
you Willing to Contribute Anonymized Cases?
4.
Are
you Willing to Contribute Anonymized Cases?
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