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Immunomodulatory Agent

IVIG for POTS (iSTAND Trial)

Phase 1 & 2

Waitlist Available

Led By Steven Vernino, MD, PhD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed personal history or family history of defined autoimmune disease including Hashimoto's thyroiditis, celiac disease, antiphospholipid syndrome, rheumatoid arthritis, SLE, or Sjogren's syndrome

One or more serum autoantibodies (ANA ≥ 1:160, gAChR antibody > 0.2 nmol/L, positive ENA, aPL, TTG, gliadin) or inflammatory markers (ESR > 30, CRP > 2, low C3 complement or low immunoglobulin IgG level)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

iSTAND Trial Summary

This trial is testing whether IVIG, a treatment for autoimmune diseases, can help with symptoms of POTS, a syndrome characterized by an increased heart rate when standing.

Who is the study for?

This trial is for adults with POTS who have moderate to severe autonomic symptoms and signs of autoimmunity, such as certain autoantibodies or a personal/family history of autoimmune diseases. Participants must be stable on current medications and able to walk. Pregnant or breastfeeding women, those with poor vein access, previous immunosuppression therapy or IVIG treatment, allergies to blood products, kidney/liver disease, recent thrombosis, or other major medical issues are excluded.Check my eligibility

What is being tested?

The study tests if IVIG (Gamunex-C), an immune-modulating treatment, can relieve symptoms in POTS patients showing signs of autoimmunity. It compares the effects of IVIG against Albumin (a plasma protein solution) in improving patient conditions.See study design

What are the potential side effects?

IVIG may cause side effects like headaches including migraine-like pain after infusion (aseptic meningitis), allergic reactions including skin rashes and breathing difficulties, potential hemolysis (breakdown of red blood cells), and possible kidney function impact.

iSTAND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I or someone in my family has an autoimmune disease like Hashimoto's, celiac, or rheumatoid arthritis.

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I have high levels of certain antibodies or markers indicating inflammation.

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I can walk by myself at the time of screening.

Select...

I experience moderate to severe symptoms related to my body's automatic functions.

Select...

I have been diagnosed with POTS.

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I have swallowing or digestion problems that have caused me to lose weight.

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My oral medication has not changed in the last 3 months.

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I am 18 or older and can give my consent.

iSTAND Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improvement in symptoms measured by change in COMPASS-31 score.

iSTAND Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Treatment IVIG ArmActive Control1 Intervention

IVIG (Gammunex-C) infusion (0.4 gm/kg) every week for 4 weeks, then every 2 weeks for 8 weeks (12 weeks total).

Group II: Treatment Albumin ArmPlacebo Group1 Intervention

albumin infusion (0.4 gm/kg) every week for 4 weeks then every 2 weeks for 8 weeks (12 weeks total) during

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Grifols Biologicals, LLCIndustry Sponsor

32 Previous Clinical Trials

9,426 Total Patients Enrolled

Dysautonomia InternationalOTHER

5 Previous Clinical Trials

389 Total Patients Enrolled

5 Trials studying Postural Orthostatic Tachycardia Syndrome

389 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,769 Total Patients Enrolled

1 Trials studying Postural Orthostatic Tachycardia Syndrome

350 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome

Media Library

IVIG (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03919773 — Phase 1 & 2

Postural Orthostatic Tachycardia Syndrome Research Study Groups: Treatment IVIG Arm, Treatment Albumin Arm

Postural Orthostatic Tachycardia Syndrome Clinical Trial 2023: IVIG Highlights & Side Effects. Trial Name: NCT03919773 — Phase 1 & 2

IVIG (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03919773 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently participating in the experiment?

"At present, this clinical trial is no longer enrolling participants. After first being posted on October 29th 2018 and last edited on January 21st 2022, it has concluded recruitment of patients. If you're searching for additional studies, there are currently 120 trials with Tachycardia as a focus point that accept volunteers and 166 research projects associated with Treatment IVIG Arm actively recruiting participants."

Answered by AI

Are there any current opportunities for participation in this experiment?

"Per clinicaltrials.gov, this investigation is no longer enrolling patients at the present time - having first been posted on October 29th 2018 and last updated January 21st 2022. Nevertheless, 286 other medical trials are actively seeking participants right now."

Answered by AI

What medical disorders can be addressed by Treatment IVIG Arm?

"Treatment IVIG Arm is a conventional approach to reduce the symptoms of shock and hypovolemia. Additionally, it has been used successfully in cases such as mediastinitis, peritonitis, and even Bruton's agammaglobulinemia."

Answered by AI

Is this experiment unprecedented in the field?

"Treatment IVIG Arm has been under investigation since 2007, when it was initially studied by the Celgene Corporation. After this inaugural trial involving 47 patients, Treatment IVIG Arm obtained Phase 1 & 2 drug approval. Currently 166 active clinical studies are occurring in 965 cities and 47 countries worldwide."

Answered by AI

Who else is applying?

What state do they live in?

California

How old are they?

18 - 65

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

What site did they apply to?

UT Southwestern Medical Center

What questions have other patients asked about this trial?

How long and how often are screening visits?

PatientReceived no prior treatments

Why did patients apply to this trial?

I’ve tried so MANY things for my dysautonomia! While my treatment protocols help.. I can’t and haven’t had a “normal” life in well over a decade! I have gastroparesis, pots, ect. I lost my marriage because I was “sick” I lost my career as a teacher.. I just want a shot at having a somewhat “normal” life again.

PatientReceived no prior treatments

Recent research and studies

The NeurologistJournal

Spectrum of Autonomic Nervous System Impairment in Sjögren Syndrome

Goodman, Brent P., Amy Crepeau, Priya S. Dhawan, Julie A. Khoury, and Lucinda A. Harris. 2017. “Spectrum of Autonomic Nervous System Impairment in Sjögren Syndrome”. The Neurologist. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/nrl.0000000000000134.

clinicaltrials.govStudy

IVIG (Gamunex-C) Treatment Study for POTS Subjects

Steven Vernino MD PhD 2018. "IVIG (Gamunex-C) Treatment Study for POTS Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03919773.