Recruiting

Testing a new vitamin D treatment for teens with kidney disease

Plain-English translation of NCT07494045 on ClinicalTrials.gov ↗ · Source last updated August 2026 · Translation generated August 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing a new medication called to help teenagers with advanced kidney disease who also don't have enough vitamin D in their bodies. The study will measure how safe the medication is, how well it works, and what happens to it once it's in your body. Over 8 weeks, participants will take the medication by mouth each night to see if it can help control the body's calcium and phosphorus levels.

When kidneys don't work well, they can't regulate vitamin D properly, which causes serious problems with calcium, phosphorus, and a hormone called parathyroid hormone. This trial is testing whether this medication could be a better way to treat these imbalances in teens with kidney disease.

Do you qualify?

You likely qualify if…

you are between 8 and 17 years old and weigh at least 88 pounds
you have been diagnosed with stage 3 or 4 chronic kidney disease for at least 6 months
you have low vitamin D levels (below 30 ng/mL) and high parathyroid hormone levels (above 85 pg/mL)
you are willing to stop or adjust certain vitamin D and calcium supplements before and during the study
you can swallow capsules whole and commit to taking medication every night for 8 weeks
if you're female and could become pregnant, you agree to use birth control during the study

You likely don't qualify if…

you have received a kidney transplant or had a transplant rejection in the past 6 months
you have had surgery to remove your parathyroid glands or are planning to have that surgery
your calcium levels have been normal or high (9.8 mg/dL or higher) in the past 3 months
you are currently taking certain other medications that treat parathyroid hormone or bone metabolism
you are pregnant, breastfeeding, or unwilling to use birth control if you could become pregnant

What participation looks like

You will take one capsule of the medication by mouth every night at bedtime for 8 weeks. During the study, you'll have several visits to the clinic where doctors will draw blood to check your kidney function, vitamin D levels, calcium, and phosphorus. The study team will monitor you closely to make sure the medication is safe and working as expected, and you'll need to stop or adjust any other vitamin D or calcium supplements you're currently taking.

AI-generated summary from trial data · Aug 21, 2026 · Not medical advice

Trial locations(5 sites)

United States

OPKO Site, Kansas City, Missouri

OPKO Site, Columbus, Ohio

OPKO Site, Philadelphia, Pennsylvania

OPKO Site, Greenville, South Carolina

OPKO Site, Madison, Wisconsin