Paricalcitol for Secondary Hyperparathyroidism in Pediatric Kidney Disease

Recruiting at 14 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: VDRAs

Must not be taking: Calcitonin, Bisphosphonates, Glucocorticoids, Calcimimetics

Disqualifiers: Kidney transplant, Parathyroidectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial requires a washout period for participants who are not new to vitamin D receptor activators (VDRA). You must stop taking certain medications like calcitonin, bisphosphonates, and high doses of glucocorticoids 4 weeks before dosing. You also cannot take calcimimetics during the study.

What data supports the idea that Paricalcitol for Secondary Hyperparathyroidism in Pediatric Kidney Disease is an effective drug?

The available research shows that Paricalcitol effectively reduces high levels of parathyroid hormone (PTH) in children with secondary hyperparathyroidism due to chronic kidney disease. It is as effective as another drug called calcitriol and is generally well tolerated, meaning it doesn't cause many side effects. One study highlighted that Paricalcitol led to a significant decrease in PTH levels in children aged 10-16, with minimal adverse effects. Additionally, Paricalcitol has been shown to improve survival rates in dialysis patients compared to calcitriol. This makes it a useful option for managing this condition in children. ^{1 2 3 4 5}

What safety data exists for paricalcitol in treating secondary hyperparathyroidism in children with kidney disease?

Paricalcitol, also known as Zemplar, is a synthetic vitamin D2 analog used to treat secondary hyperparathyroidism in children with chronic kidney disease. Clinical trials have shown that paricalcitol effectively reduces elevated parathyroid hormone (PTH) levels and is generally well tolerated in both children and adults. It has a lower incidence of prolonged hypercalcemia compared to calcitriol. Studies have reported minimal adverse events in children aged 10-16 years, indicating its safety and efficacy. However, more research is needed, especially for younger children, to further establish its safety profile. ^{1 2 3 4 6}

Is the drug Paricalcitol a promising treatment for secondary hyperparathyroidism in children with kidney disease?

Yes, Paricalcitol is a promising drug for treating secondary hyperparathyroidism in children with kidney disease. It effectively reduces high levels of parathyroid hormone, is well-tolerated, and has fewer side effects compared to other treatments. It also helps protect the kidneys and heart, making it a valuable option for managing this condition. ^{1 2 3 6 7}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dosing Period 1

Participants receive paricalcitol oral solution three times a week for 12 weeks

12 weeks

Dosing Period 2

Continuation of paricalcitol oral solution treatment for an additional 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Paricalcitol

Trial Overview 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.

Participant Groups

Group I: Participants Receiving Paricalcitol Experimental Treatment 1 Intervention

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

Paricalcitol is already approved in United States, European Union for the following indications:

Approved in United States as Zemplar for:

• Secondary hyperparathyroidism associated with chronic kidney disease

Approved in European Union as Paricalcitol for:

• Secondary hyperparathyroidism associated with chronic kidney disease

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

Paricalcitol is a synthetic vitamin D2 analog that effectively reduces elevated parathyroid hormone (PTH) levels in patients with secondary hyperparathyroidism due to chronic renal failure, and it is well tolerated in both adults and children.

In clinical trials, paricalcitol demonstrated similar efficacy to calcitriol while having a comparable safety profile, particularly regarding the risk of prolonged hypercalcemia, making it a valuable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on paricalcitol in secondary hyperparathyroidism. Robinson, DM., Scott, LJ.[2019]

Paricalcitol has been shown to be effective and safe in reducing parathyroid hormone (PTH) levels by over 30% in children aged 10-16 years with chronic kidney disease (CKD) and mineral and bone disorder (CKD-MBD), indicating its potential as a treatment option.

The study highlights the urgent need for more clinical trials focused on the use of paricalcitol in younger children with CKD-MBD, as early and effective treatment is crucial for their growth and long-term health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral paricalcitol: expanding therapeutic options for pediatric chronic kidney disease patients. Freundlich, M., Abitbol, CL.[2019]

Paricalcitol is an effective treatment for secondary hyperparathyroidism in patients with chronic renal failure, as it significantly reduces elevated parathyroid hormone (PTH) levels and is well tolerated in both adults and children.

In clinical trials, paricalcitol demonstrated similar efficacy and safety profiles compared to calcitriol, with no significant increase in the risk of prolonged hypercalcemia or elevated calcium-phosphorus product.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paricalcitol: a review of its use in the management of secondary hyperparathyroidism. Robinson, DM., Scott, LJ.[2018]

Oral paricalcitol effectively reduced elevated intact parathyroid hormone (iPTH) levels in children aged 10-16 years with stages 3-5 chronic kidney disease (CKD), with 27.8% of participants in the stage 3/4 CKD study achieving significant reductions compared to none in the placebo group.

The treatment was well tolerated, with fewer adverse events reported in the paricalcitol group compared to placebo (38.9% vs. 88.9%), although some children experienced clinically meaningful hypercalcemia (21%) during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of paricalcitol in children with stages 3 to 5 chronic kidney disease. Webb, NJA., Lerner, G., Warady, BA., et al.[2018]

Early treatment with calcitriol in chronic kidney disease can help prevent secondary hyperparathyroidism and its associated complications, but it may lead to side effects like hypercalcemia and hyperphosphatemia.

Newer vitamin D analogues, such as 19-nor-paracalcitol and doxercalciferol, show promise in managing secondary hyperparathyroidism with fewer side effects on calcium and phosphorus levels, although their long-term effects on bone health and vascular calcification are still under investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are new vitamin D analogues in renal bone disease superior to calcitriol? Salusky, IB.[2018]

Paricalcitol, a metabolite of vitamin D2, is safer than calcitriol for long-term use in chronic kidney disease (CKD) as it causes hypercalcemia less frequently while providing stronger nephroprotective effects.

Combining paricalcitol with lozartan enhances its nephroprotective benefits and reduces cardiovascular mortality in patients with CKD, indicating its potential for improving overall kidney and heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of D2 vitamin metabolite paricalcitol in nephroprotective strategy in chronic disease of the kidneys]. Milovanov, IuS., Kozlovskaia, LV., Milovanova, LIu.[2014]

Paricalcitol, a new vitamin D analogue, effectively reduces parathyroid hormone (PTH) levels by 60% in patients with secondary hyperparathyroidism while maintaining normal serum calcium levels, indicating its efficacy and safety compared to traditional treatments like calcitriol.

In clinical trials, paricalcitol demonstrated a lower incidence of hypercalcemia and hyperphosphatemia, suggesting it may be a safer alternative for managing secondary hyperparathyroidism without the risks associated with increased calcium and phosphorus levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy of secondary hyperparathyroidism with 19-nor-1alpha,25-dihydroxyvitamin D2. Martin, KJ., González, EA., Gellens, ME., et al.[2019]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on paricalcitol in secondary hyperparathyroidism. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Oral paricalcitol: expanding therapeutic options for pediatric chronic kidney disease patients. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Paricalcitol: a review of its use in the management of secondary hyperparathyroidism. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of paricalcitol in children with stages 3 to 5 chronic kidney disease. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Are new vitamin D analogues in renal bone disease superior to calcitriol? [2018]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The role of D2 vitamin metabolite paricalcitol in nephroprotective strategy in chronic disease of the kidneys]. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Therapy of secondary hyperparathyroidism with 19-nor-1alpha,25-dihydroxyvitamin D2. [2019]