Status:
UNKNOWN
Cinacalcet in Paediatric Secondary Hyperparathyroidism (SHPT) Due to Chronic Kidney Disease (CKD)
Lead Sponsor:
ENRICO VERRINA
Conditions:
Secondary Hyperparathyroidism
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
PHASE3
Brief 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 tr...
Detailed Description
This multicenter, intra-subject controlled, open-label, active-treatment study will assess in children affected by Secondary Hyperparathyroidism, aged 2-18 years on chronic dialysis not responsive to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01479088
Start Date
March 1 2010
End Date
December 1 2013
Last Update
November 24 2011
Active Locations (5)
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1
U.O. Nefrologia e Dialisi - Istituto di Ricovero e Cura a Carattere Scientifico Giannina Gaslini
Genoa, Italy, Italy, 16147
2
U.O. Nefrologia e Dialisi- Ospedale Giovanni XXIII
Bari, Italy, 70100
3
U.O. Nefrologia e Dialisi Pediatrica - Clinica De Marchi
Milan, Italy, 20100
4
U.O. Nefrologia e Dialisi - Ospedale Santobono
Naples, Italy, 80100