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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
For entry into the Dosing Period (for VDRA-naive participants or VDRA non-naive participants who have completed the Washout Period), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.
For entry into the Washout Period (for vitamin D receptor activator [VDRA] non-naive participants), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 through week 24
Awards & highlights

Study Summary

This trial is studying the safety and effectiveness of a medication called paricalcitol in children with kidney disease who are receiving either peritoneal dialysis or hemodialysis. The trial will last for 24 weeks, and will be divided into two 12-week periods.

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.Check my eligibility
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.See study design
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
Select...
I meet the lab criteria for my age to start the treatment phase, as per the study's protocol.
Select...
I meet the lab criteria for my age to stop my current vitamin D treatment.
Select...
I have been on dialysis for my stage 5 CKD for at least 30 days.
Select...
I am currently being treated for SHPT.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Hypercalcemia During Dosing Period 1
Percentage of Participants Who Achieve Positive Response During Dosing Period 1
Secondary outcome measures
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%
Viral Infection
7%
Leg Cramps
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

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

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
501,028 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,862 Total Patients Enrolled

Media Library

Paricalcitol (Vitamin D Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04064827 — Phase 3
Secondary Hyperparathyroidism Research Study Groups: Participants Receiving Paricalcitol
Secondary Hyperparathyroidism 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still looking for qualified participants for this experiment?

"That is correct, the clinical trial indicated on clinicaltrials.gov is currently seeking participants. The 16 patients needed for the study will be recruited from 14 different site locations. This particular study was first posted on September 16th 2020 and updated most recently on April 20th 2022."

Answered by AI

Is Paricalcitol known to cause any adverse health effects?

"Paricalcitol has received a score of 3 for safety. This is due to being in Phase 3 trials, which have both supporting efficacy data and multiple rounds of supportive safety data."

Answered by AI

What other medical studies have featured Paricalcitol?

"The origin of paricalcitol can be traced back to Son Espases University Hospital in 2014. Since then, there have been a total of 54 completed studies on the topic. Currently, 10 clinical trials are ongoing with many of them based in Atlanta, Georgia."

Answered by AI

How many individuals are being helped through this trial?

"That is correct, the trial is still open for recruitment according to information posted on clinicaltrials.gov. The postings date back to September 16th 2020 with the most recent update being from April 20th 2022. They are looking for a total of 16 participants which will be drawn from 14 different locations."

Answered by AI

What are the researchers trying to achieve with this clinical trial?

"The primary outcome of this clinical trial will be assessed over a 12-week period and is the percentage of participants who achieve positive response during dosing period 1. Secondary outcomes include the percentage of participants who achieve positive response during dosing period 2 (defined as two consecutive >= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL [16.5-33.0 picomole[pmol]/L]), the percentage of participants who achieve two consecutive >= 30% reductions in iPTH from baseline during dosing period 1, and the incidence"

Answered by AI

What are the prerequisites for volunteers of this research project?

"This clinical trial is looking for 16 individuals with secondary hyperparathyroidism between the ages of 0 and 9. There are several key requirements that participants must meet, which are as follows: They must based on their age, they must be currently diagnosed with or being treated for SHPT, have CKD stage 5 and have been receiving PD or HD for at least 30 days before initial screening, and if applicable, meet the appropriate laboratory criteria for washout period entry."

Answered by AI

What are the main conditions that Paricalcitol is used to treat?

"Paricalcitol can improve the lives of patients struggling with stage 3 or stage 4 chronic kidney disease, including those that require hemodialysis."

Answered by AI

For this particular research, are senior citizens welcomed as participants?

"According to the guidelines set for this clinical trial, children aged 0-9 are able to participate."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
2020. "A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04064827.
All > Chronic Kidney Disease > Thyroid
~6 spots leftby Jun 2026
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