Pediatric Chronic Kidney Disease Safety and Efficacy

Amgen

Status and phase: Terminated; Phase 3

Conditions: Hyperparathyroidism, Secondary; Chronic Kidney Disease; Hyperparathyroidism; Secondary Hyperparathyroidism; Kidney Disease

Treatments: Drug: placebo; Drug: Standard of Care; Drug: cinacalcet capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT01277510

20070208

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.

Full description

Secondary hyperparathyroidism (SHPT) is a condition that can develop early in patients with chronic kidney disease (CKD), usually gets worse over time, and is known to cause problems for patients on dialysis. Children on dialysis can have a wide range of bone and growth issues, and common treatments have a chance of making these things worse by increasing serum calcium and serum phosphorus. Cinacalcet has been shown to be effective in controlling parathyroid hormone (PTH), calcium and phosphorus in adults. The purpose of this study is to show that including cinacalcet in the treatment of SHPT will lower the levels of intact parathyroid hormone (iPTH) in a larger number of pediatric patients with CKD who are receiving dialysis, compared to a treatment regimen that does not include cinacalcet.

Enrollment: 43 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 6 to less than 18 years at screening
• Diagnosed with CKD and SHPT receiving hemodialysis or peritoneal dialysis for ≥ 2 months before randomization
• Dry weight ≥ 12.5 kg at screening
• iPTH obtained from the central laboratory must be > 300 pg/mL (31.8 pmol/L)
• Serum calcium (corrected) obtained from the central laboratory must be ≥ 8.8 mg/dL (2.2 mmol/L)
• Serum phosphorus obtained from the central laboratory ≥ 4.0 mg/dL (1.3 mmol/L) for children 6 to less than 12 years old, or ≥ 3.5 mg/dL (1.1 mmol/L) for children 12 to less than 18 years old
• Subjects already receiving vitamin D sterols (either calcitriol or a synthetic analog), a stable dose within the last 2 months prior to randomization
• Subjects taking growth hormone, a stable dose defined as no change > than 20% in the last 2 months prior to randomization
• Subjects on anti-convulsant medication must be on a stable dose for 3 months, and have a therapeutic blood level of the anti-convulsant at the time of randomization
• Subjects must be on a dialysate calcium concentration of ≥ 2.5 mEq/L (1.25 mmol/L) for at least 2 months prior to randomization

Exclusion criteria

• Underwent parathyroidectomy in the last 6 months
• Anticipated parathyroidectomy within 6 months after randomization
• Received therapy with cinacalcet (sensipar/mimpara) within the last month
• A new onset of seizure or worsening of a pre-existing seizure disorder within the last 3 months
• Scheduled date for kidney transplant from a known living donor that makes completion of the study unlikely

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.

Treatment:

Drug: Standard of Care

Drug: placebo

Cinacalcet

Experimental group

Description:

Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks.

Treatment:

Drug: cinacalcet capsule

Drug: Standard of Care