What side effects are associated with this type of intervention?

Common side effects of treatments for Secondary Hyperparathyroidism, particularly synthetic vitamin D analogs like Paricalcitol, include hypercalcemia (elevated calcium levels), hyperphosphatemia (elevated phosphate levels), and gastrointestinal issues such as nausea and vomiting. There is also a risk of vitamin D toxicity if not properly monitored. These side effects need careful management to ensure patient safety and treatment efficacy.

What prior FDA approvals exist?

The FDA has approved several treatments for Secondary Hyperparathyroidism (SHPT), particularly in patients with chronic kidney disease (CKD). Paricalcitol, a synthetic vitamin D analog, is one such treatment that effectively reduces PTH levels. Other similar FDA-approved drugs include calcitriol and doxercalciferol, which are also vitamin D analogs used to manage SHPT by lowering PTH levels. These treatments help in managing the mineral and bone disorder associated with CKD.

What other types of research exist?

Promising novel alternatives to Paricalcitol for treating Secondary Hyperparathyroidism (SHPT) include Etelcalcetide and Evocalcet. Both are calcimimetics that act by enhancing the sensitivity of the calcium-sensing receptors on the parathyroid gland, thereby reducing PTH levels. These alternatives have shown efficacy in clinical trials and offer different mechanisms of action compared to vitamin D analogs.

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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

Participant is currently diagnosed with and/or being treated for secondary hyperparathyroidism (SHPT).

Be younger than 18 years old

Must not have

Participant is scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant recipient.

Participant is receiving calcimimetics at the time of Screening or is expected to initiate calcimimetics at any time throughout the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12 through week 24

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a medication called paricalcitol, which is taken by mouth, in young children with severe kidney disease and hormone imbalance. The goal is to see if it is safe and effective in balancing their hormone levels. Paricalcitol has been shown to be effective in reducing calcium and phosphorus levels in patients with kidney issues.

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.

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.

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

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I am currently being treated for SHPT.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for a kidney transplant from a living donor soon or have already received one.

Select...

I am currently taking or will start taking calcimimetics during the study.

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I have been on specific bone or steroid medications for over 4 weeks.

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I cannot take medications by mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12 through week 24

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Hypercalcemia During Dosing Period 1

Percentage of Participants Who Achieve Positive Response During Dosing Period 1

Secondary study objectives

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

Leg Cramps

Viral Infection

Hypercalcemia

Allergic Infection

Polydipsia

Dehydration

Urinary Tract Infection

Chest Pain

Sinusitis

Headache

General Infection

Asthenia

Fever

Infection Fungal

Conjuctivitis

Syncope

Depression

Increased Cough

Polyuria

Abdominal Pain

Photophobia

Decreased libido

Hypotension

Nausea

Esophageal ulcer

Somnolence

Back Pain

Vomiting

Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

Paricalcitol Treatment

Calcitriol Treatment

Cholecalciferol

Supplemental

Awards & Highlights

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.

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Secondary Hyperparathyroidism (SHPT) is commonly treated with vitamin D analogs like paricalcitol, which help reduce elevated parathyroid hormone (PTH) levels. Paricalcitol works by binding to the vitamin D receptor in the parathyroid gland, thereby inhibiting PTH synthesis and secretion. This is crucial for SHPT patients, as high PTH levels can lead to bone disease and cardiovascular complications. Additionally, managing calcium and phosphate levels through diet, phosphate binders, and calcimimetics is essential to prevent further complications. These treatments collectively help maintain mineral balance and reduce the risk of bone and cardiovascular issues in SHPT patients.