Encaleret for Hypocalcemia
(CALIBRATE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called encaleret for individuals with Autosomal Dominant Hypocalcemia Type 1 (ADH1), a condition that lowers calcium levels in the blood. Researchers aim to evaluate the effectiveness and safety of encaleret compared to the usual care, which includes calcium supplements and active Vitamin D. Participants with specific gene changes related to ADH1 who have experienced its symptoms may be suitable candidates. The goal is to determine if encaleret can better manage calcium levels in these patients. 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?
Yes, you may need to stop taking certain medications. If you are on thiazide diuretics, phosphate binders, magnesium or potassium supplements, or potassium-sparing diuretics, you will need to discontinue them before starting the trial. There are specific timeframes for stopping these medications, such as at least 14 days for thiazides and at least one day for phosphate binders.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. If you are on thiazide diuretics, you must stop them at least 14 days before a specific visit. You also need to stop phosphate binders (except calcium salts), magnesium or potassium supplements, and potassium-sparing diuretics before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that encaleret is generally safe for people. Studies have found that encaleret helps maintain balanced calcium levels in individuals with Autosomal Dominant Hypocalcemia Type 1 (ADH1). In earlier research, participants used encaleret for up to 18 months without major problems. No serious side effects were reported, indicating its safety for long-term use. These findings provide promising evidence about the safety of encaleret for those considering participation in a clinical trial.12345
Why do researchers think this study treatment might be promising for hypocalcemia?
Unlike the standard of care for hypocalcemia, which involves calcium supplements and active Vitamin D, encaleret offers a unique approach by directly adjusting calcium levels in the body. Researchers are excited about encaleret because it targets the underlying regulation of calcium, potentially allowing for more precise control of calcium levels. This could lead to more effective management of hypocalcemia symptoms with fewer side effects compared to traditional treatments.
What evidence suggests that this trial's treatments could be effective for hypocalcemia?
Research has shown that encaleret, which participants in this trial may receive, may help treat Autosomal Dominant Hypocalcemia Type 1 (ADH1). In one study, encaleret helped maintain stable calcium levels in patients over time. This stability suggests it could be a reliable way to manage the condition. Reports noted that patients taking encaleret experienced significant improvements in their mineral balance. Overall, these findings support the idea that encaleret can be effective for people with ADH1.12678
Who Is on the Research Team?
Calcilytix Medical Director
Principal Investigator
Calcilytix Therapeutics, Inc., a BridgeBio company
Are You a Good Fit for This Trial?
This trial is for people with a genetic variant causing hypoparathyroidism (ADH1), aged 16-18 with closed growth plates, not on certain diuretics or supplements, and meeting specific treatment criteria. Excluded are those recently on PTH treatments, had seizures or thyroid surgery, pregnant/nursing women, low Vitamin D levels, certain viral infections, or severely reduced kidney function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
SoC Optimization
Participants undergo a standard of care optimization phase to confirm eligibility for the main study
SoC Maintenance
Participants maintain their standard of care dose, adjusted only for safety concerns
Randomized Treatment
Participants are randomized to receive either encaleret or SoC treatment, with doses adjusted based on blood calcium levels
Dose Maintenance
Participants maintain their dose of encaleret or SoC
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-Term Extension (optional)
Participants may opt into continuation of encaleret treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Calcium supplements and active Vitamin D
- Encaleret
Find a Clinic Near You
Who Is Running the Clinical Trial?
Calcilytix Therapeutics, Inc., a BridgeBio company
Lead Sponsor