We're sorry. This study is closed and no longer recruiting participants.
STUDY BASICS
Are you the parent of a child aged 5-17 who has stage 3 or 4 chronic kidney disease, and who is not on dialysis? If so, your child may be eligible to participate in a research study to help find out if an investigational study medication called Hectorol® is safe and effective for children with stage 3 or 4 chronic kidney disease. Compensation provided.
STUDY PURPOSE
Children who have stage 3 or 4 kidney disease are at an increased risk of developing bone disorders due to an imbalance in calcium and parathyroid hormone levels in the body. Bone disorders associated with chronic kidney disease include short stature, deformed bones, and other health problems. The purpose of this research study is to help find out if an investigational study medication called Hectorol® is safe and effective for children with stage 3 or 4 chronic kidney disease. Hectorol® is a form of vitamin D designed to maintain healthy blood levels of calcium and parathyroid hormone. Hectorol® is FDA approved for use in adults with chronic kidney disease, but has not been tested in children.COULD THIS STUDY BE RIGHT FOR YOUR CHILD?
- Ages 5-17
- Weigh more than 33 pounds
- Have stage 3 or 4 chronic kidney disease
- Not on dialysis
- Able and willing to swallow capsules
WHAT PARTICIPANTS CAN EXPECT
Participation in this study involves up to 12 in-person study visits over 28 weeks. Following an initial screening period to find out if your child is eligible for the study, participants will be randomly assigned (like the flip of a coin) to receive either the investigational drug Hectorol® or Rocaltrol®. Rocaltrol® is an alternative treatment for children with chronic kidney disease and is very similar to Hectorol®. Both Hectorol® and Rocaltrol® are capsules taken by mouth. Procedures and assessments during the course of the study may include blood draws, physical exams, alcohol and drug tests, pregnancy tests, and completing a patient diary.IRB: 201708416A
- An Open-Label, Randomized, Parallel Group Study to Assess the Safety and Efficacy of Hectorol® (doxercalciferol capsules) in Pediatric Patients with Chronic Kidney Disease Stages 3 and 4 with Secondary Hyperparathyroidsim Not Yet on DialysisMEET THE RESEARCHER
Christina Nguyen
Christina R. Nguyen, MD, is an Assistant Professor at the University of Pittsburgh School of Medicine. Dr. Nguyen is a graduate of Northeast Ohio Medical University and specializes in Pediatric Nephrology.