Cincalcet and Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism

NCT01143987 | Completed Phase 4

• 1 other identifier: CRE-2010.084-T
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Active parathyroid glands among renal dialysis patients contribute to calcified and hardened blood vessels. Such damage to the blood vessels, in turn, takes a significant toll in terms of cardiovascular disease. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. The investigators designed an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.

Conditions

Hyperparathyroidism; Arterial Stiffness

Keywords

hyperparathyroidism; pulse wave velocity; end-stage renal disease; arterial stiffness

Outcome Measures

Primary Outcomes (1)

• Aortic pulse wave velocity after the cinacalcet treatment

  as before

  change in aortic pulse wave velocity at 52 weeks from baseline

Secondary Outcomes (5)

• Percent change in the values for parathyroid hormone levels

  within one year of treatment with cinacalcet

• Change in calcium levels

  within one year of treatment with cinacalcet

• Aortic pulse wave velocity after the cinacalcet treatment

  change in aortic pulse wave velocity at 26 weeks from baseline

• Change in phosphorus levels

  within one year of cinacalcet treatment

• Change in calcium-phosphorus product

  within one year of cinacalcet treatment

Study Arms (1)

Cinacalcet

EXPERIMENTAL

Oral cinacalcet

Drug: Cinacalcet

Interventions

Cinacalcet DRUG

starting with 25 mg daily dose with titration, maximum dose 100 mg daily

Also known as: Sensipar

Cinacalcet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• plasma parathyroid hormone level of at least 300 pg/ml (31.8 pmol/L)
• aged 18 or older on peritoneal dialysis for at least three months
• willingness to give written consent and comply with the study protocol

You may not qualify if:

• evidence of cancer, active infection or diseases with limited life expectancy
• diseases known to cause hypercalcaemia
• adjusted serum calcium level below 2.1 mmol/L (8.4 mg/dL) after correction for albumin
• participation in another interventional study within last 30 days of randomization
• history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures
• patients receiving drugs with a narrow therapeutic index and metabolized by cytochrome P-450 2D6 (which is inhibited by cinacalcet): flecainide, thioridazine and most tricyclic antidepressants

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, SAR, Hong Kong

Location

Related Publications (1)

• Chow KM, Szeto CC, Kwan BC, Cheng PM, Pang WF, Leung CB, Li PK. Effect of cinacalcet treatment on vascular arterial stiffness among peritoneal dialysis patients with secondary hyperparathyroidism. Nephrology (Carlton). 2014 Jun;19(6):339-44. doi: 10.1111/nep.12223.

  PMID: 24589316 DERIVED

MeSH Terms

Conditions

Hyperparathyroidism; Kidney Failure, Chronic

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Kai Ming Chow, MBChB

  Chinese University of Hong Kong, Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 15, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

HK (1)