Intravenous immunoglobulin therapy for small fiber neuropathy: study protocol for a randomized controlled trial

Table 2 Study flow chart – laboratory assessments

	Screening	Treatment phase				End of Treatment	Follow-up⁵
Lab assessment	- 10 days (Day -10 to Day 0)	Week 0 Baseline/ Day 1	Completion of baseline infusion (Day 2 or 3 or 4)	3-6 Days after completion of baseline infusion	Week 3,6,9 (± 3 days)	Week 12 (± 3 days)	Month 4, 5, 6
Immunofixation	X
Pregnancy Test (Serum β HCG)	X
TSH¹ / regular T4	X
Fasting blood glucose, vitamin B12²	X
Serum Retain³	X					X
Urinalysis	X			X
IgG⁴		X	X⁴	X	X	X
Hematology/CBC (hematocrit, hemoglobin, WBC, RBC, platelets)	X	X		X	X	X
Creatinine, Blood urea nitrogen	X	X		X	X	X
AST/ALT, LDH, potassium, bilirubin, CK		X	X⁴		X	X
Gamma-GT		X	X⁴	X		X

¹ TSH to be conducted at screening if results not available since SFN diagnosis. Regular T4 automatically run by LabCorp if TSH determined to be above the upper limits of normal
² To be conducted at screening if results not available since SFN diagnosis
³ 2 aliquots required at screening (one for viral retain and one for possible future antibody testing); 1 aliquot required at both Week 12 (for possible future antibody testing)
⁴ Samples to be obtained immediately after completion of entire baseline infusion. If the entire baseline infusion is completed in 2 days, then samples are to be collected post-infusion on Day 2. If the entire baseline infusion is completed in 3 or 4 days, then samples are to be collected post-infusion on Day 3 or 4 respectively
⁵ The follow-up period will be performed by standardized telephone call interviews

ISSN: 1745-6215