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Completed

NCT Number: NCT01101113

Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level

This study is designed in order to investigate the effect of cinacalcet in combination with routine conventional medical management for treatment of secondary hyperparathyroidism (SHPT) and Ca, P control. This study will compare the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for dialysis patients.

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Key information

Conditions

Secondary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital, Seoul, Korea, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Peritoneal dialysis patients with secondary HPT(iPTH > 300 pg/mL)
  • > 18 yr of age, < 70
  • had receive PD for > 3 mo,
  • intact PTH level > 300 pg/ml and <1000 pg/ml
  • albumin corrected Ca level >= 9.0 mg/dL

Exclusion criteria

  • pregnant or breast-feeding,
  • had undergone parathyroidectomy within previous 3 mo,
  • are involved in other clinical trial within 30 d
  • had received cinacalcet therapy previously.

Treatment and study plan

Cinacalcet

Drug

cinacalcet 25mg qd or 50 mg qd

Control

Drug

vit D + P binder

Primary outcomes

  1. > 30% reduction from baseline of intact parathyroid hormone (iPTH)

    Time frame: 20 weeks

Secondary outcomes

  1. Achievement of treatment goal of intact parathyroid hormone (iPTH) (150~300 pg/ml)

    Time frame: 20 weeks

  2. Achievement of targets for mean Ca x P (<55 mg2/dL2), Ca (<9.5 mg/dL), P (<5.5 mg/dL)

    Time frame: 20 weeks

  3. Achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) simultaneously

    Time frame: 20 weeks

  4. Vascular calcification score

    Time frame: 20 weeks

    Abdominal aortic calcification score (AAC, 0-24) will be measured at baseline and at 20 weeks according to Kauppila et al (Atherosclerosis 2004)

  5. Normalization of serum alkaline phosphatase

    Time frame: 20 weeks

    Serum alkaline phosphatase measured at baseline and 20 weeks

  6. Serum FGF-23

    Time frame: baseline and 20th week

    Elevated serum levels of fibroblast growth factor-23 (FGF23) is associated with adverse outcomes in dialyzed patients. Therefore, we added analysis of change in FGF23 levels between two treatments to explore the cinacalcet effect in lowering FGF23.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Jeil-Kirin Pharmaceutical Inc.

Registry information

Official study title

Phase 4 Study of Cinacalcet Efficacy in Combination With Vitamin D for the Treatment of Secondary Hyperparathyroidism in Peritoneal Dialysis Patients

Acronym: CUPID

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 9, 2010
Registry last updated
Jun 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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