Cinacalcet in Paediatric Secondary Hyperparathyroidism (SHPT) Due to Chronic Kidney Disease (CKD)

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Twelve-month, multicenter, intra-subject controlled (retrospective-prospective), open-label, active-treatment study to evaluate the dose-response and pharmacokinetics (PK) of cinacalcet HCl for the treatment of Secondary Hyperparathyroidism (SHPT) in paediatric subjects with chronic kidney disease (CKD) on dialysis, followed by 12-month study extension.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ENRICO VERRINA
• Treatments: Cinacalcet; Cinacalcet Hydrochloride

Criteria

Inclusion Criteria:

• Parents'/guardian written informed consent, and child's assent

• Age > 2 and <18 years;

• A dry body weight (BW) >10.49 Kg in males and >9.95 Kg in females, respectively;

• Inpatient or outpatient status at the time of enrolment;

• Males or females. Female subjects sexually active must be neither pregnant nor breastfeeding, and must lack childbearing potential from screening visit to the end of the safety follow-up

• On stable hemodialysis (HD) or peritoneal dialysis (PD) for their CKD for at least one month before entering the 6-month pre-treatment period;

• Plasma iPTH levels > 300 pg/mL, AND

• Plasma Ca levels > 9.4 mg/dL (with normal serum albumin level), AND

• Plasma P levels <6.5 mg/dL in patients younger than 6 years, or <6.0mg/dL in older patients, OR

• Ca x P product > 60;

• Records' availability for the following parameters 6 months prior to study entry:

demographic information, physical examination, height and dry weight, auxological/anthropometric indices, blood pressure values, Kt/V urea, plasma iPTH, calcium, phosphorus, and alkaline phosphatise levels, blood pH and bicarbonate, serum creatinine/urea, C reactive protein (CRP) levels, liver function tests, blood count, blood 25(OH) vitamin D3 level.

Exclusion Criteria:

• The following laboratory values: Hb<9.0 g/dL, WBC<2000/mm3 (2x109/L), platelets <150,000/mm3 (150x109/L) only in subjects who are otherwise eligible for PK/PD assessments; abnormal liver function, defined by a total bilirubin ≥2 times the upper limit of normal values, ASAT, ALAT, γ-GT levels ≥2 times the ULN values.

• Any other lab values that in the opinion of the investigator might place the subject at unacceptable risk for participation in the study.

• History of malignancy (active malignancy, or off therapy since less than 1 year)

• History of diseases causing hypercalcemia

• Chronic inflammatory diseases (C-Reactive Protein-CRP >2 times the upper limit of normal values) requiring a concomitant corticosteroid or immunosuppressive therapy

• History of infectious diseases (including opportunistic infections) within 4 weeks prior to study entry

• Evidence as assessed by the Investigator of active or latent bacterial, viral or fungal infections at the time of potential enrollment, including subjects with evidence of HIV infection.

• Hepatitis-B surface antigen-positive subjects only in subjects who are otherwise eligible for PK/PD assessments

• Hepatitis C antibody-positive subjects who are also PCR-positive or RIBA positive only in subjects who are otherwise eligible for PK/PD assessments

• Use of recombinant human growth hormone therapy

• Use of drugs that interact with cinacalcet disposition

• Previous use of cinacalcet