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Completed

NCT Number: NCT01447368

Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

This is a pilot, prospective randomized controlled study with the primary objective to evaluate and compare medical treatment of severe SHPT, namely oral cinacalcet versus surgical treatment, that is, parathyroidectomy with forearm autografting, on the progression of coronary artery and valvular calcification and left ventricular mass index in endstage renal disease patients receiving peritoneal dialysis over 12 months. The change in arterial stiffening, left ventricular volume, aortic valve calcium score and bone mineral density, nutritional status and biochemical parameters, quality of life measures will be evaluated as secondary objectives of this study.

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Key information

About this study

Patients with severe secondary hyperparathyroidism (SHPT) are frequently complicated with vascular calcification. There is some suggestion that subtotal parathyroidectomy may reduce or stabilize vascular calcium scores in dialysis patients. Experimental data suggests that SHPT plays an important role in mediating uraemic arterial disease and that parathyroidectomy largely prevented the development of calcification. Cinacalcet has emerged as a novel therapy for the treatment of SHPT and has been shown to reduce the need for surgical parathyroidectomy. However, their effects on vascular, cardiac, bone and nutrition status have not been evaluated and compared with parathyroidectomy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ESRD patients on long-term peritoneal dialysis treatment, with elevated intact parathyroid hormone (iPTH) levels > 800pg/mL.
  • Patients with parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan.
  • Patients with age between 18 - 75 years.

Exclusion criteria

  • Patients with background valvular heart disease
  • Patients who are unfit for general anaesthesia
  • Patients with acute myocardial infarction within recent two months
  • Patients with poor general condition
  • Patients with plans for living related kidney transplant within 1 year
  • Patients with previous history of parathyroidectomy
  • Patients with underlying malignancy
  • Patients with hepatic dysfunction

Treatment and study plan

Cinacalcet

Drug

oral cinacalcet 25mg once daily as a start and up titrated by 25mg daily according to response in lowering PTH and maximum oral dose allowed is 100mg daily

Other names: Regpara

Surgical total parathyroidectomy with forearm autografting

Procedure

Surgical total parathyroidectomy with forearm autografting will be performed

Primary outcomes

  1. Change in coronary artery calcium score

    Time frame: 52 weeks

    Change in coronary artery calcium score

  2. change in left ventricular mass index

    Time frame: 52 weeks

    change in left ventricular mass index

Secondary outcomes

  1. change in left ventricular volume and ejection fraction

    Time frame: 52 weeks

    change in left ventricular volume and ejection fraction

  2. Change in aortic pulse wave velocity

    Time frame: 24 and 52 weeks

    Change in aortic pulse wave velocity

  3. Change in aortic valve and mitral valve calcium score

    Time frame: 52 weeks

    Change in aortic valve and mitral valve calcium score

  4. change in augmentation index and heart rate adjusted augmentation index

    Time frame: over 52 weeks

    change in augmentation index and heart rate adjusted augmentation index

  5. change in bone mineral density at forearm, spine and femur

    Time frame: 52 weeks

    change in bone mineral density at forearm, spine and femur

  6. Quality of Life (QOL) scores

    Time frame: 52 weeks

    Kidney Disease Outcome Quality Initiatives (KDOQI QOL domain scores)

  7. change in resting energy expenditure

    Time frame: 24 and 52 weeks

    Change in resting energy expenditure

  8. change in lean muscle mass

    Time frame: 52 weeks

    Change in lean muscle mass

  9. change in handgrip strength

    Time frame: 24 and 52 weeks

    Change in handgrip strength

  10. Change in subjective global assessment

    Time frame: 24 and 52 weeks

    Change in subjective global assessment

  11. Change in serum calcium and phosphorus

    Time frame: over 52 weeks

    Change in biochemical parameter Serum calcium and phosphorus

  12. change in intact parathyroid hormone (iPTH) level

    Time frame: 52 weeks

    Change in biochemical parameter Parathyroid hormone

  13. Change in alkaline phosphatase

    Time frame: over 52 weeks

    Change in biochemical parameter alkaline phosphatase

  14. change in serum albumin

    Time frame: over 52 weeks

    CHange in biochemical parameter serum albumin

  15. change in lymphocyte count

    Time frame: over 52 weeks

    change in lymphocyte count

  16. change in lipid profile

    Time frame: over 52 weeks

    change in lipid profile

  17. change in systolic and diastolic blood pressure

    Time frame: over 52 weeks

    change in systolic and diastolic blood pressure

  18. change in subendocardial viability ratio

    Time frame: over 52 weeks

    change in subendocardial viability ratio

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Comparison of Medical Therapy (Oral Cinacalcet) Versus Surgical Therapy (Total Parathyroidectomy) on Vascular/Valvular Calcification in Chronic Peritoneal Dialysis Patients With Secondary Hyperparathyroidism - A Pilot Randomized Study

Acronym: PROCEED

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Oct 6, 2011
Registry last updated
Oct 12, 2021

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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