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Currently Enrolling
Interventional

KIND

Phase 3 study for the treatment of Secondary Hyperparathyroidism (SHPT) in pediatric subjects with stage 5 Chronic Kidney Disease (CKD).

Brief Description

The KIND study is testing the safety, efficacy, and pharmacokinetics of paricalcitol oral solution in participants of ages 0 to 9 years that have been diagnosed with Secondary Hyperparathyroidism (SHPT) associated with stage 5 Chronic Kidney Disease (CKD) receiving Peritoneal Dialysis (PD) or Hemodialysis (HD).

Trial Physician / Study Coordinator

Jessica Timmer

Email Phone
Site Name

Holtz Childrens Hospital, University of Miami
1580 NW 10th Ave, Room 542 Miami FL 33136-1013

Sponsor

Abbvie

Study Drug

Paricalcitol

Estimated enrollment

16 patients

Estimated end date

February 2027

If there is not a site for a clinical trial nearby, you can ask the study team about the possibility of travel reimbursements (i.e., paying you back for your travel costs). Alternatively, you can ask about the possibility of participating from home.
Currently Enrolling
Interventional

KIND

Phase 3 study for the treatment of Secondary Hyperparathyroidism (SHPT) in pediatric subjects with stage 5 Chronic Kidney Disease (CKD).

Brief Description

The KIND study is testing the safety, efficacy, and pharmacokinetics of paricalcitol oral solution in participants of ages 0 to 9 years that have been diagnosed with Secondary Hyperparathyroidism (SHPT) associated with stage 5 Chronic Kidney Disease (CKD) receiving Peritoneal Dialysis (PD) or Hemodialysis (HD).

Trial is for people with

2-9 years old patients diagnosed with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) stage 5 receiving peritoneal dialysis (PD) or hemodialysis (HD).

Study Goal

The goal of the study is to assess the effect of Paracalcitol on blood calcium levels and intact parathyroid hormone (iPTH) in pediatric patients with Secondary Hyperparathyroidism (SHPT) associated with stage 5 Chronic Kidney Disease (CKD).

What is involved for the Patient?

Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks.

About the drug or intervention

Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser.

Miami, FL
Frequently Asked Questions

Nephrotic Syndrome is not a disease itself, but rather a group of signs and symptoms that result from damage in the part of the kidney that filters blood (glomeruli).

Common symptoms include:

  • Foamy urine (called proteinuria) caused by protein “spilling” into the urine
  • Severe swelling in parts of the body, most noticeably around the eyes, hands, feet, and abdomen (called edema)
  • Weight gain due to a buildup of extra fluid
  • Fatigue
  • Loss of appetite
  • Low levels of protein in the blood (hypoalbuminemia)
  • Higher than normal fat and cholesterol levels in the blood (hyperlipidemia)

Nephrotic Syndrome can typically be diagnosed with a urine test.

Nephrotic Syndrome can be “primary” or “secondary” in nature.

Diseases that affect only the kidneys are called primary causes of Nephrotic Syndrome. Doctors often call these diseases “idiopathic,” which means that they arise from an unknown cause. Some of these diseases include:

  • Minimal Change Disease (MCD) – most common in children
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Membranous Nephropathy (MN) – most common in adults
  • IgA Nephropathy (IgAN)

Secondary Nephrotic Syndrome is caused by an underlying, systemic condition like diabetes, lupus, HIV, and others.

Clinical studies are any studies that involve people. There are two main types: observational and interventional. In an observational trial, researchers track health outcomes over time in groups of participants to look for patterns that help us better understand a disease. In an interventional trial, participants receive specific interventions, which can include new treatments or behavorial changes (e.g., diet changes). To learn more about clinical research, please visit the NephCure website.