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Vitamin D Analog

Paricalcitol for Secondary Hyperparathyroidism in Pediatric Kidney Disease

Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is currently diagnosed with and/or being treated for secondary hyperparathyroidism (SHPT).
Be younger than 18 years old
Must not have
Participant is scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant recipient.
Participant is receiving calcimimetics at the time of Screening or is expected to initiate calcimimetics at any time throughout the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 through week 24
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a medication called paricalcitol, which is taken by mouth, in young children with severe kidney disease and hormone imbalance. The goal is to see if it is safe and effective in balancing their hormone levels. Paricalcitol has been shown to be effective in reducing calcium and phosphorus levels in patients with kidney issues.

Who is the study for?
This trial is for children aged 0-9 with stage 5 chronic kidney disease on dialysis, who have secondary hyperparathyroidism. They must meet specific lab criteria and have been on dialysis for at least a month. Kids can't join if they're getting a kidney transplant soon, had parathyroid surgery recently, can't take oral meds, or are on certain bone-related treatments.
What is being tested?
The study tests Paricalcitol's safety and effectiveness in managing SHPT in young kids with advanced kidney disease undergoing dialysis. It spans over 24 weeks with two consecutive 12-week dosing periods to assess how the body processes the drug.
What are the potential side effects?
Possible side effects of Paricalcitol may include high levels of calcium in the blood (hypercalcemia), nausea, vomiting, dizziness and potentially affecting growth rates or causing bone abnormalities due to its action on calcium regulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently being treated for SHPT.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for a kidney transplant from a living donor soon or have already received one.
Select...
I am currently taking or will start taking calcimimetics during the study.
Select...
I have been on specific bone or steroid medications for over 4 weeks.
Select...
I cannot take medications by mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 through week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 through week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Hypercalcemia During Dosing Period 1
Percentage of Participants Who Achieve Positive Response During Dosing Period 1
Secondary study objectives
Incidence of Hypercalcemia During Dosing Period 2
Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1
+7 more

Side effects data

From 2010 Phase 4 trial • 109 Patients • NCT01265615
23%
Hypophospatemia
17%
Fatigue
13%
Increased hypertension
13%
Edema
13%
Diarrhea
13%
Pain
10%
Taste perversions
10%
Arthritis
10%
Dizziness
10%
Gastroenteritis
10%
Vertigo
10%
Rhinitis
10%
Bronchitis
10%
Rash
7%
Leg Cramps
7%
Viral Infection
7%
Hypercalcemia
7%
Allergic Infection
7%
Polydipsia
7%
Dehydration
7%
Urinary Tract Infection
3%
Chest Pain
3%
Sinusitis
3%
Headache
3%
General Infection
3%
Asthenia
3%
Fever
3%
Infection Fungal
3%
Conjuctivitis
3%
Syncope
3%
Depression
3%
Increased Cough
3%
Polyuria
3%
Abdominal Pain
3%
Photophobia
3%
Decreased libido
3%
Hypotension
3%
Nausea
3%
Esophageal ulcer
3%
Somnolence
3%
Back Pain
3%
Vomiting
3%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paricalcitol Treatment
Calcitriol Treatment
Cholecalciferol
Supplemental

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants Receiving ParicalcitolExperimental Treatment1 Intervention
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paricalcitol
2013
Completed Phase 4
~1730

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
Secondary Hyperparathyroidism (SHPT) is commonly treated with vitamin D analogs like paricalcitol, which help reduce elevated parathyroid hormone (PTH) levels. Paricalcitol works by binding to the vitamin D receptor in the parathyroid gland, thereby inhibiting PTH synthesis and secretion. This is crucial for SHPT patients, as high PTH levels can lead to bone disease and cardiovascular complications. Additionally, managing calcium and phosphate levels through diet, phosphate binders, and calcimimetics is essential to prevent further complications. These treatments collectively help maintain mineral balance and reduce the risk of bone and cardiovascular issues in SHPT patients.

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,019 Previous Clinical Trials
519,867 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
441 Previous Clinical Trials
160,316 Total Patients Enrolled

Media Library

Paricalcitol (Vitamin D Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04064827 — Phase 3
SHPT Research Study Groups: Participants Receiving Paricalcitol
SHPT Clinical Trial 2023: Paricalcitol Highlights & Side Effects. Trial Name: NCT04064827 — Phase 3
Paricalcitol (Vitamin D Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04064827 — Phase 3
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