Tenapanor for Cystic Fibrosis-Related Constipation

Overseen By Chloe Butzel, BA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Massachusetts General Hospital

Must not be taking: Antibiotics, Laxatives

Disqualifiers: Severe CFrC, DIOS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests tenapanor, a medication approved for IBS with constipation, to determine its effectiveness for people with cystic fibrosis who experience constipation. Participants will take a pill twice daily for four weeks and complete surveys and daily diaries about their symptoms and bowel movements. This trial suits those with cystic fibrosis who have experienced constipation issues for several months, such as straining during bowel movements or having fewer than three bowel movements a week. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

You will need to stop taking your regular bowel regimen medications, like fiber supplements or laxatives, two weeks before starting the study drug. However, you can use osmotic laxatives if needed during the study.

Is there any evidence suggesting that tenapanor is likely to be safe for humans?

Research has shown that tenapanor is generally safe and well-tolerated. In studies on irritable bowel syndrome with constipation (IBS-C), tenapanor proved effective and did not cause major side effects for most people. It works by altering sodium levels in the gut, which helps increase bowel movements. This method has been safe for previous patients.

Additionally, the FDA has already approved tenapanor for IBS-C, indicating it has passed thorough testing for that condition. While the current trial explores its use for constipation related to cystic fibrosis, the safety data from IBS-C patients is reassuring. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cystic fibrosis-related constipation?

Tenapanor is unique because it works differently from current treatments for cystic fibrosis-related constipation. Most existing options focus on softening stool or promoting bowel movement through osmotic effects. However, Tenapanor targets and inhibits the NHE3 sodium transporter in the gut, which reduces sodium absorption and increases water content in the intestines, facilitating easier bowel movements. Researchers are excited about Tenapanor because its novel mechanism of action offers a new way to manage constipation with potential for improved effectiveness and fewer side effects compared to traditional laxatives.

What evidence suggests that tenapanor might be an effective treatment for cystic fibrosis-related constipation?

Research has shown that tenapanor, a drug approved by the FDA for treating IBS with constipation, can increase bowel movement frequency. Studies have found that patients taking tenapanor experience more complete spontaneous bowel movements (CSBMs), potentially relieving constipation symptoms. For constipation related to cystic fibrosis, tenapanor reduces sodium absorption in the gut, drawing water into the intestines and easing constipation. This trial will evaluate whether tenapanor can also help those with cystic fibrosis-related constipation. ^{1 3 6 7 8}

Who Is on the Research Team?

Christoher D Velez, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for cystic fibrosis patients who have constipation. They must have confirmed cystic fibrosis, meet criteria for CF-related constipation like straining or feeling of incomplete bowel evacuation, and have fewer than three spontaneous bowel movements weekly. Participants should not plan major dietary or lifestyle changes during the study.

Inclusion Criteria

I have less than 3 bowel movements a week.

I rarely have loose stools without taking laxatives.

I meet the criteria for CFrC.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive tenapanor, 50 mg tablet twice daily, for a 4-week treatment period

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tenapanor

Trial Overview The trial tests Tenapanor, an FDA-approved drug for IBS with constipation, to treat cystic fibrosis-related constipation (CFrC). Patients will take a 50 mg tablet twice daily for four weeks and complete questionnaires and diaries about their gastrointestinal symptoms and bowel movement frequency.

How Is the Trial Designed?

Group I: Cystic fibrosis patients with CF-related constipation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Ardelyx

Industry Sponsor

Trials

31

Recruited

6,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06810167?term=AREA%5BBasicSearch%5D(TENAPANOR)&rank=4

Study Details | NCT06810167 | Assessing Tenapanor as a ... There will be a statistically significant increase in spontaneous bowel movement frequency (SBM) in cystic fibrosis patients with CF-related constipation ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06810167/assessing-tenapanor-as-a-treatment-of-cf-related-constipation

Assessing Tenapanor as a Treatment of CF-related ... Tenapanor is the newest FDA-approved drug for IBS with constipation (IBS-C). This study seeks to understand tenapanor as a treatment for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7771640/

Efficacy of Tenapanor in Treating Patients With Irritable ... In that trial, treatment with tenapanor 50 mg b.i.d. resulted in significant increases in complete spontaneous bowel movements (CSBMs) and reductions in ...

4. trial.medpath.com trial.medpath.com/clinical-trial/0b6ee12d03f0cca4/nct06810167-tenapanor-treatment-cf-constipation

Assessing Tenapanor as a Treatment of CF-related ... - MedPath Tenapanor is the newest FDA-approved drug for IBS with constipation (IBS-C). This study seeks to understand tenapanor as a treatment for cystic ...

5. massgeneral.trialstoday.org massgeneral.trialstoday.org/trial/NCT06810167

Mass General - Division of Clinical Research Tenapanor is the newest FDA-approved drug for IBS with constipation (IBS-C). This study seeks to understand tenapanor as a treatment for cystic ...

6. hcplive.com hcplive.com/view/discussing-safety-tolerability-of-tenapanor-in-pediatric-ibs-c-patients-with-thomas-wallach-md

Discussing Safety, Tolerability of Tenapanor in Pediatric ... Preliminary data demonstrated that tenapanor, a first-in-class sodium/hydrogen exchanger isoform 3 (NHE3) inhibitor, was safe and well-tolerated ...

7. withpower.com withpower.com/trial/phase-3-constipation-1-2025-fc282

Tenapanor for Cystic Fibrosis-Related Constipation Tenapanor is the newest FDA-approved drug for IBS with constipation (IBS-C). This study seeks to understand tenapanor as a treatment for cystic ...

8. contemporarypediatrics.com contemporarypediatrics.com/view/safety-tolerability-of-tenapanor-in-pediatric-ibs-c-patients-with-thomas-wallach-md

Safety, tolerability of tenapanor in pediatric IBS-C patients, ... Preliminary data demonstrated that tenapanor, a first-in-class sodium/hydrogen exchanger isoform 3 (NHE3) inhibitor, was safe and well-tolerated ...