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Paricalcitol for Secondary Hyperparathyroidism in Pediatric Kidney Disease
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2010 Phase 4 trial • 109 Patients • NCT01265615Trial Design
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Who is running the clinical trial?
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- I am scheduled for a kidney transplant from a living donor soon or have already received one.I am currently taking or will start taking calcimimetics during the study.I had surgery to remove my parathyroid gland within the last 3 months.I have been on specific bone or steroid medications for over 4 weeks.I plan to stop dialysis within 3 months after my first screening visit.I meet the lab criteria for my age to start the treatment phase, as per the study's protocol.I meet the lab criteria for my age to stop my current vitamin D treatment.I have been on dialysis for my stage 5 CKD for at least 30 days.I cannot take medications by mouth.I am currently being treated for SHPT.
- Group 1: Participants Receiving Paricalcitol
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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"
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."
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."
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."
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