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Could a vitamin d pill help kids with kidney disease avoid dialysis?

NCT ID NCT02859896

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This phase 3 trial compares two oral vitamin D therapies—Hectorol (doxercalciferol) and Rocaltrol (calcitriol)—in children aged 5 to 18 with chronic kidney disease stages 3 or 4 who have high parathyroid hormone levels but are not yet on dialysis. The main goal is to see if Hectorol can safely reduce parathyroid hormone by at least 30% over 12 weeks. The study also tracks side effects and how the drug moves through the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
doxercalciferol (Hectorol)
What this could lead to
If successful, this could offer a safer or more effective option to manage secondary hyperparathyroidism in children with chronic kidney disease, potentially delaying the need for dialysis.
What could go wrong
This is a small phase 3 trial with only 21 participants, so results may not apply broadly. The drug may cause side effects like high calcium or phosphorus levels, and it is not a cure for kidney disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

21 people

The number who actually took part.

Started

Jan 2017

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria : * Male or female aged 5 to 18 years old. * Weight ≥15 kg. * Chronic kidney disease (CKD) Stage 3 or 4 not on dialysis, defined as glomerular filtration rate (GFR) between 15 and 59 mL/min/1.73m\^2 (established by Schwartz equation) at Week -2 visit. * Intact parathyroid hormone (iPTH) value \>100 pg/mL for CKD Stage 3 or \>160 pg/mL for CKD Stage 4, at Week -2 visit. * Signed informed consent/assent form. Exclusion criteria: * The participant had a serum 25-hydroxyvitamin D level \<30 ng/mL at screening. * The participant had a corrected calcium ≥10 mg/dL at the Week -2 visit. * The participant had a serum phosphorus \>4.5 mg/dL for children 13 to 18 years of age; \>5.8 mg/dL for children 5 to 12 years of age at the Week -2 visit. * The participant was anticipated to require maintenance hemodialysis within 3 months. * The participant used cinacalcet or vitamin D sterol therapies such as calcitriol, doxercalciferol, or paricalcitol within 14 days prior to the baseline visit. * The participant had a history of, or active, symptomatic heart disease within 12 months prior to the baseline (Week 0) visit. * The participant had a chronic gastrointestinal disease (ie, malabsorption, severe chronic diarrhea, chronic ulcerative colitis, or ileostomy). * The participant had primary hyperparathyroidism or has had a total parathyroidectomy. * The participant had an active malignancy. * The participant was unable to swallow a capsule in size similar to the Hectorol® and Rocaltrol® capsules. * The participant had a history of sensitivity or allergy to doxercalciferol, calcitriol or other vitamin D analogs. * The participant used aluminum or magnesium-based binders. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

secondary hyperparathyroidism of renal origin

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Secondary hyperparathyroidism-chronic kidney disease

Contacts and locations

Locations

  • Cedars-Sinai Medical Center- Site Number : 8400033

    Los Angeles, California, 90048, United States

  • Children's of Alabama- Site Number : 8400022

    Birmingham, Alabama, 35233, United States

  • Cohen Children's Medical Center- Site Number : 8400017

    New Hyde Park, New York, 11040, United States

  • Duke University Medical Center- Site Number : 8400034

    Durham, North Carolina, 27710, United States

  • East Carolina University- Site Number : 8400025

    Greenville, North Carolina, 27858, United States

  • Goryeb Chidlren's Hospital- Site Number : 8400016

    Morristown, New Jersey, 07962, United States

  • Greenville Memorial Hospital- Site Number : 8400027

    Greenville, South Carolina, 29605, United States

  • Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400010

    Hackensack, New Jersey, 07601, United States

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7500539, Chile

  • Investigational Site Number : 1520004

    Concepción, Biobio, 4070038, Chile

  • M Health Fairview University of Minnesota Medical Center - West Bank- Site Number : 8400014

    Minneapolis, Minnesota, 55454, United States

  • Marshfield Medical Center - Marshfield- Site Number : 8400001

    Marshfield, Wisconsin, 54449, United States

  • Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400008

    Miami, Florida, 33155, United States

  • Rush University Medical Center- Site Number : 8400020

    Chicago, Illinois, 60612, United States

  • Texas Children's Hospital- Site Number : 8400013

    Houston, Texas, 77030, United States

  • The Mount Sinai Hospital- Site Number : 8400007

    New York, New York, 10029, United States

  • UPMC Children's Hospital of Pittsburgh- Site Number : 8400028

    Pittsburgh, Pennsylvania, 15224, United States

  • University of California Davis Health- Site Number : 8400005

    Sacramento, California, 95817, United States

  • University of Miami Hospital- Site Number : 8400006

    Miami, Florida, 33136, United States

  • University of Utah Health Hospital- Site Number : 8400026

    Salt Lake City, Utah, 84132, United States

  • Vanderbilt University Medical Center- Site Number : 8400024

    Nashville, Tennessee, 37292, United States

  • Virginia Commonwealth University Medical Center- Site Number : 8400009

    Richmond, Virginia, 23219, United States

  • Yale University School of Medicine- Site Number : 8400029

    New Haven, Connecticut, 06510, United States

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