Cinacalcet in Paediatric Secondary Hyperparathyroidism (SHPT) Due to Chronic Kidney Disease (CKD)
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ClinicalTrials.gov Identifier: NCT01479088 |
Recruitment Status : Unknown
Verified November 2011 by ENRICO VERRINA, Istituto Giannina Gaslini.
Recruitment status was: Recruiting
First Posted : November 24, 2011
Last Update Posted : November 24, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Secondary Hyperparathyroidism | Drug: Cinacalcet HCl | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Twelve-month, Multicenter, Intra-subject Controlled (Retrospective-prospective), Open-label, Active-treatment Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Cinacalcet Hydrochloride for the Treatment of Secondary Hyperparathyroidism (SHPT) in Paediatric Subjects With Chronic Kidney Disease (CKD) on Dialysis, Followed by 12-month Study Extension. |
Study Start Date : | March 2010 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: cinacalcet tab or extemporaneous solution po added to SoC
Subjects who meet all inclusion/exclusion criteria at baseline will be given cinacalcet 30mg film-coated tablet, for oral use added to phosphate binders and vitamin D analogue. For subjects receiving a cinacalcet dose <30mg, commercially available cinacalcet 30mg tab will be ground and diluted with a 5% dextrose solution. Then, an aliquot of this solution corresponding to the individually prescribed dose will be administered as indicated. Initial dosing of cinacalcet will be 0.5-0.75mg/kg or 30 mg po once daily (OD) each evening with food. During the cinacalcet dose-titration 6-month period for efficacy assessment, the dose will be increased on monthly basis by 0.5 mg/kg or by 30mg OD to achieve the target iPTH value <180 pg/mL, as tolerated by the subject, up to maximum of 180mg OD in absence of signs of hypocalcemia, according to the current summary of product characteristics. |
Drug: Cinacalcet HCl
The 6-month pre-treatment period will be followed by a run-in period with a baseline evaluation prior to the drug administration, followed by a 6-month cinacalcet dose titration period, during which the dose will be increased on monthly basis by 0.5 mg/kg or by 30 mg OD up to the achievement of target iPTH value <180 pg/mL as tolerated by the patient
Other Name: Mimpara® |
- Composite EP, e.g. the proportion of patients who will have a reduction from baseline of >= 25% in mean iPTH levels with concomitant values for plasma P <6 mg/dL and Ca between 8.4 and 10.5 mg/dL or the Ca x P product <60 [ Time Frame: 6 months ]This composite EP will address the needed information on the appropriate dose of cinacalcet to be adopted in paediatric patients, and especially in younger children, as well as on the impact of treatment with calcimimetics on serum Ca and P levels, and on SHPT control over the long term
- The long term control of iPTH level < 300 pg/mL [ Time Frame: 18 months ]
- The long term control of PTH, Ca, P, and the Ca x P product values [ Time Frame: 18 months ]
- The PK/ PD ( iPTH and testosterone) profile at individual patient level [ Time Frame: 12 months ]
- The long term auxological indices and patient growth velocity during cinacalcet treatment [ Time Frame: 18 months ]
- The proportion of patients with treatment-emergent adverse events (AEs), serious AEs (SAEs), and laboratory abnormalities over long term [ Time Frame: 18 months ]

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Ages Eligible for Study: | 2 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479088
Contact: Enrico E. Verrina, MD | +390105636276 | enricoverrina@ospedale-gaslini.ge.it | |
Contact: Ornella Della Casa Alberighi, MD PhD | +390105636461 | ornelladellacasa@ospedale-gaslini.ge.it |
Italy | |
U.O. Nefrologia e Dialisi- Ospedale Giovanni XXIII | Active, not recruiting |
Bari, Italy, 70100 | |
U.O. Nefrologia e Dialisi - Istituto di Ricovero e Cura a Carattere Scientifico Giannina Gaslini | Recruiting |
Genoa, Italy, 16147 | |
Contact: Enrico E Verrina, MD +390105636276 enricoverrina@ospedale-gaslini.ge.it | |
Contact: Ornella Della Casa Alberighi, MD PhD +390105636461 ornelladellacasa@ospedale-gaslini.ge.it | |
Principal Investigator: Enrico E. Verrina, MD | |
U.O. Nefrologia e Dialisi Pediatrica - Clinica De Marchi | Active, not recruiting |
Milan, Italy, 20100 | |
U.O. Nefrologia e Dialisi - Ospedale Santobono | Active, not recruiting |
Naples, Italy, 80100 | |
U.O. Nefrologia e Dialisi - Ospedale Bambino Gesù | Active, not recruiting |
Rome, Italy, 00100 |
Principal Investigator: | Enrico E. Verrina, MD | U.O. Nefrologia e Dialisi; Istituto di Ricovero e Cura a Carattere Scientifico Giannina Gaslini |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | ENRICO VERRINA, Director of Dialysis Unit, Istituto Giannina Gaslini |
ClinicalTrials.gov Identifier: | NCT01479088 |
Other Study ID Numbers: |
IGG_ev_003 2009-016797-32 ( EudraCT Number ) |
First Posted: | November 24, 2011 Key Record Dates |
Last Update Posted: | November 24, 2011 |
Last Verified: | November 2011 |
Cinacalcet PK Secondary Hyperparathyroidism |
Paediatric Chronic Kidney Disease Dialysis |
Neoplasm Metastasis Kidney Diseases Renal Insufficiency, Chronic Hyperparathyroidism Hyperparathyroidism, Secondary Urologic Diseases Neoplastic Processes Neoplasms Pathologic Processes |
Renal Insufficiency Parathyroid Diseases Endocrine System Diseases Cinacalcet Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Calcimimetic Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |