What is the mechanism of action of this treatment?

The most common treatments for Acute Pancreatitis focus on reducing inflammation and managing symptoms. Oral tacrolimus, a calcineurin inhibitor, works by suppressing the immune response and reducing the production of pro-inflammatory cytokines, which can help mitigate the inflammatory process in the pancreas. This is crucial for Acute Pancreatitis patients as excessive inflammation can lead to severe complications and prolonged recovery. Other treatments typically include supportive care such as fluid resuscitation, pain management, and nutritional support to allow the pancreas to heal.

What side effects are associated with this type of intervention?

Common treatments for acute pancreatitis include supportive care such as fluid resuscitation, pain management, and nutritional support. Calcineurin inhibitors like tacrolimus, which are being studied for their potential to reduce inflammation, have known side effects including nephrotoxicity, neurotoxicity, hypertension, hyperglycemia, and increased risk of infections. Broadly, treatments for acute pancreatitis can also lead to complications such as gastrointestinal bleeding, pancreatic necrosis, and systemic inflammatory response syndrome (SIRS).

What other types of research exist?

Promising novel alternatives to oral tacrolimus for acute pancreatitis patients include: 1) Neutrophil elastase inhibitors, which have shown potential in reducing inflammation in acute lung injury and may be applicable to pancreatitis. 2) Activated protein C, which has anti-inflammatory properties and has been tested in acute lung injury. 3) Ketoconazole, which has been studied for its anti-inflammatory effects in acute respiratory distress syndrome and may have potential in pancreatitis. These alternatives should be discussed with a healthcare provider to determine the best course of treatment.

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Nonsteroidal Anti-inflammatory Drug (NSAID)

Indomethacin + Tacrolimus to Prevent Post-ERCP Pancreatitis (INTRO Trial)

Q: What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Acute Pancreatitis that involve calcineurin inhibitors like tacrolimus. The management of Acute Pancreatitis typically includes supportive care such as fluid resuscitation, pain management, and nutritional support. Research is ongoing to explore the potential benefits of various drugs, including tacrolimus, which is being studied for its anti-inflammatory properties in preventing post-ERCP pancreatitis.

Phase 3

Recruiting

Led By Venkata S. Akshintala, M.D.

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

ERCP in a patient with prior biliary sphincterotomy, but without anticipated pancreatogram.

Pancreatic head malignancy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days of ercp

Awards & highlights

Pivotal Trial

Summary

This trial is testing if taking oral tacrolimus before a specific medical procedure can prevent pancreatitis. The study focuses on patients who are at risk of developing pancreatitis after this procedure. Tacrolimus works by stopping the release of substances in the pancreas that cause inflammation. Tacrolimus has been studied for its potential to prevent pancreatitis after this procedure by reducing inflammation.

Who is the study for?

This trial is for adults undergoing ERCP at participating centers who can consent. It's not for those with certain pancreas or kidney conditions, pregnant or breastfeeding women, people allergic to tacrolimus/NSAIDs, or those currently on immune modulators.

What is being tested?

The study tests if oral tacrolimus before an ERCP procedure can prevent post-ERCP pancreatitis compared to a placebo. Participants will receive either the drug or a placebo in a controlled environment.

What are the potential side effects?

Tacrolimus may cause side effects like nausea, headaches, high blood pressure, and increased risk of infection. Indomethacin might lead to stomach pain, heartburn, dizziness and could potentially affect kidney function.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a procedure to open my bile duct but don't expect a pancreas duct imaging.

Select...

My cancer is located in the head of the pancreas.

Select...

I am currently taking tacrolimus or an immune modulator.

Select...

I do not have a rectum.

Select...

I cannot take certain medications like tacrolimus or NSAIDs due to health reasons.

Select...

I am scheduled for a procedure to change or remove a bile duct stent.

Select...

I have been diagnosed with Type 3 Sphincter of Oddi dysfunction.

Select...

I have chronic pancreatitis with calcium buildup.

Select...

My kidney function is severely reduced or I have sudden kidney injury.

Select...

I have had a procedure on my bile ducts due to pancreas divisum.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days of ercp

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days of ercp

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of ercp for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The proportion of subjects in each study group with Post ERCP Acute Pancreatitis (PEP)

Secondary study objectives

The proportion of subjects in each study group with moderate-severe Post-ERCP Pancreatitis

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Oral Tacrolimus + IndomethacinExperimental Treatment2 Interventions

* Tacrolimus Capsule 1-2 hours prior to the endoscopy * Rectal Indomethacin immediately after ERCP, in high-risk patients

Group II: Oral Placebo + IndomethacinPlacebo Group2 Interventions

* Placebo Capsule 1-2 hours prior to the endoscopy * Rectal Indomethacin immediately after ERCP, in high-risk patients

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tacrolimus capsule

2011

Completed Phase 3

~90

Rectal Indomethacin

2014

N/A

~950

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Pancreatitis focus on reducing inflammation and managing symptoms. Oral tacrolimus, a calcineurin inhibitor, works by suppressing the immune response and reducing the production of pro-inflammatory cytokines, which can help mitigate the inflammatory process in the pancreas. This is crucial for Acute Pancreatitis patients as excessive inflammation can lead to severe complications and prolonged recovery. Other treatments typically include supportive care such as fluid resuscitation, pain management, and nutritional support to allow the pancreas to heal.