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Hectorol for Chronic Kidney Disease with Hyperparathyroidism
Study Summary
This trial is testing the effect of Hectorol capsules in reducing elevated levels of iPTH, as well as the safety profile of Hectorol capsules compared to Rocaltrol capsules.
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.Trial Design
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Who is running the clinical trial?
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- I have taken cinacalcet or vitamin D drugs like calcitriol in the last 14 days.Your corrected calcium level is higher than 10 mg/dL at the Week -2 visit.I have a long-term gut condition like severe diarrhea or ulcerative colitis.I have primary hyperparathyroidism or have had all my parathyroid glands removed.I currently have cancer.I am allergic to certain vitamin D medications.I am between 5 and 18 years old.I have had heart problems in the last year.I have moderate to severe kidney disease but am not on dialysis.Your vitamin D level in your blood is less than 30 ng/mL at the time of screening.I might need dialysis within the next 3 months.I cannot swallow pills similar in size to Hectorol or Rocaltrol.I weigh at least 15 kilograms.My parathyroid hormone levels are high for my stage of kidney disease.Your blood test shows high levels of phosphorus. For children 13 to 18 years old, the level is above 4.5 mg/dL, and for children 5 to 12 years old, the level is above 5.8 mg/dL.I am currently using aluminum or magnesium-based binders.
- Group 1: Hectorol
- Group 2: Rocaltrol
- 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
What is the current legal status of Doxercalciferol?
"Doxercalciferol (GZ427397) has received a score of 3 for safety. Phase 3 trials have some evidence of efficacy and multiple rounds of supporting data for safety."
How many individuals are participating in the research project?
"This study is not actively recruiting right now, however, it was updated recently on May 3rd, 2022. If you are looking for other studies, there are 1175 trials for neoplasm metastasis and 7 trials for Doxercalciferol (GZ427397) that are currently searching for patients."
Does this research project welcome participants who are under seventy years old?
"The age requirements for this particular clinical trial are that potential participants must be between 5 to 18 years old. Out of the 80 clinical trials available for those under 18, this is one of 1123 trials open to patients that are over 65."
Are there different sites in North America conducting this trial?
"Currently, this trial is recruiting patients from 48 different locations, which include Hackensack, Greenville, and Houston. If you enroll in this trial, it would be helpful to choose a clinic nearest to your location to cut down on travel time."
What is the standard medical use of Doxercalciferol (GZ427397)?
"Doxercalciferol (GZ427397) is not only used to treat hypoparathyroidism, but also stage 4 chronic kidney disease, kidney failure, and secondary hyperparathyroidism."
Could you please list the other areas in which Doxercalciferol (GZ427397) has been tested?
"Currently, there are 7 Doxercalciferol (GZ427397) trials underway. 1 of these is in the critical third phase. Most of the research is being conducted in Beijing, but there are 72 total locations running these studies."
Are people with the required qualifications still able to sign up for this experiment?
"Unfortunately, this study is not currently enrolling patients. Although, it is worth noting that the study was first posted on 1/19/2017 and was most recently updated on 5/3/2022. Additionally, if you are looking for other studies, there are 1175 trials for patients with neoplasm metastasis and 7 for Doxercalciferol (GZ427397) that are presently enrolling patients."
How can I become a subject of this research?
"This medical study is seeking 84 patients, both male and female, aged 5 to 18, who have neoplasm metastasis. In addition to this, the following must be true of participants: they must weigh more than 15 kg, have Stage 3 or 4 Chronic Kidney Disease (CKD) but not be on dialysis, have an intact parathyroid hormone (iPTH) value that meets the study's defined thresholds, and have signed an informed consent form."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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