Paricalcitol for Secondary Hyperparathyroidism in Pediatric Kidney Disease

No longer recruiting at 23 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of paricalcitol, a vitamin D analog, for children with advanced kidney disease, particularly those with secondary hyperparathyroidism undergoing dialysis. Participants will receive the treatment three times a week for 24 weeks. The trial seeks children with stage 5 chronic kidney disease who are undergoing peritoneal or hemodialysis, with no imminent kidney transplants planned. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that paricalcitol is likely to be safe for humans?

Research has shown that paricalcitol is generally safe for individuals with kidney problems. It effectively lowers parathyroid hormone (PTH) levels in patients, whether they are on dialysis or not. In children aged 10 to 16 with chronic kidney disease, paricalcitol safely reduced PTH levels by more than 30%, suggesting potential safety for younger children as well.

Additionally, one study comparing treatments found paricalcitol to be safer than calcitriol for similar conditions. Although individual reactions can vary, these findings support the safety of paricalcitol in managing secondary hyperparathyroidism in people with kidney disease. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Paricalcitol is unique because it targets secondary hyperparathyroidism in pediatric kidney disease by specifically acting on the parathyroid hormone (PTH) pathway. Unlike other treatments that might broadly suppress PTH, paricalcitol is a synthetic vitamin D analog that selectively reduces PTH levels without significantly affecting calcium and phosphorus levels. This selectivity minimizes potential side effects like hypercalcemia, making it a promising alternative to existing therapies. Researchers are excited because paricalcitol offers a more focused approach, which could lead to better safety and effectiveness in managing this condition.

What evidence suggests that paricalcitol might be an effective treatment for secondary hyperparathyroidism in pediatric kidney disease?

Research has shown that paricalcitol, the treatment under study in this trial, effectively lowers parathyroid hormone (PTH) levels in children with chronic kidney disease. Studies have found that children aged 10 to 16 years with secondary hyperparathyroidism (SHPT) experienced a reduction of over 30% in their PTH levels. This reduction is important because high PTH levels can lead to bone problems and other health issues. In adults and older children, paricalcitol has also successfully reduced protein in urine, a common concern in kidney disease. Overall, evidence suggests that paricalcitol can help manage SHPT in younger patients by lowering PTH levels, making it a promising treatment option. ^{1 2 3 4 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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, 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3591146/

Meta-Analysis: The Efficacy and Safety of Paricalcitol for ... Paricalcitol is effective in lowering PTH in patients with CKD not yet on dialysis and is also effective in lowering proteinuria in diabetic CKD patients.

2. withpower.com withpower.com/trial/phase-3-hyperparathyroidism-8-2020-bea95

Paricalcitol for Secondary Hyperparathyroidism in Pediatric ... 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00800358

Safety and Efficacy Study of Paricalcitol Versus Calcitriol in ... The purpose of this study is to determine whether oral paricalcitol is safer and more efficacious compared to oral calcitriol in the treatment of ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9697664/

19-Nor-1-alpha-25-dihydroxyvitamin D2 (Paricalcitol ... Paricalcitol treatment resulted in a significant reduction in serum alkaline phosphatase from 148+/-23 U/L to 101+/-14 U/L (P < 0.001) in patients treated for ...

5. ajkd.org ajkd.org/article/S0272-6386(07)00640-3/abstract

Intravenous Paricalcitol for Treatment of Secondary ... The paricalcitol group had a mean decrease in iPTH level of 164 pg/mL (ng/L), whereas the placebo group had a mean increase of 238 pg/mL (ng/L; P = 0.03). There ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272638698002996

19-nor-1,25-dihydroxyvitamin D2 This study is the first blinded, randomized, multicenter clinical trial comparing a vitamin D analog with calcitriol, and shows that paricalcitol, dosed at a 4: ...