Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

NCT01447368 | Completed Phase 4

• 1 other identifier: CP-2015
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Failure; Secondary Hyperparathyroidism; Vascular Diseases

Keywords

chronic kidney disease; peritoneal dialysis; secondary hyperparathyroidism; parathyroidectomy; vascular calcification; cinacalcet

Outcome Measures

Primary Outcomes (2)

• Change in coronary artery calcium score

  Change in coronary artery calcium score

  52 weeks

• change in left ventricular mass index

  change in left ventricular mass index

  52 weeks

Secondary Outcomes (18)

• change in left ventricular volume and ejection fraction

  52 weeks

• Change in aortic pulse wave velocity

  24 and 52 weeks

• Change in aortic valve and mitral valve calcium score

  52 weeks

• change in augmentation index and heart rate adjusted augmentation index

  over 52 weeks

• change in bone mineral density at forearm, spine and femur

  52 weeks

Study Arms (2)

Cinacalcet treatment

EXPERIMENTAL

Oral Cinacalcet treatment arm, 25mg daily to be administered and gradually step up as required to control iPTH between 2 - 9 times lab reference range, Maximum dose to be given is 100mg daily

Drug: Cinacalcet

Surgical total parathyroidectomy

ACTIVE COMPARATOR

Surgical total parathyroidectomy with forearm autografting will be performed for patients randomized to this arm.

Procedure: Surgical total parathyroidectomy with forearm autografting

Interventions

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

Also known as: Regpara

Cinacalcet treatment

Surgical total parathyroidectomy with forearm autografting PROCEDURE

Surgical total parathyroidectomy with forearm autografting will be performed

Surgical total parathyroidectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital and Tung Wah Hospital

Hong Kong, 0000, Hong Kong

Location

Related Publications (2)

• Wang AY, Tang TK, Yau YY, Lo WK. Impact of Parathyroidectomy Versus Oral Cinacalcet on Bone Mineral Density in Patients on Peritoneal Dialysis With Advanced Secondary Hyperparathyroidism: The PROCEED Pilot Randomized Trial. Am J Kidney Dis. 2024 Apr;83(4):456-466.e1. doi: 10.1053/j.ajkd.2023.10.007. Epub 2023 Nov 30.

  PMID: 38040277 DERIVED

• Wang AY, Lo WK, Cheung SC, Tang TK, Yau YY, Lang BH. Parathyroidectomy versus oral cinacalcet on cardiovascular parameters in peritoneal dialysis patients with advanced secondary hyperparathyroidism (PROCEED): a randomized trial. Nephrol Dial Transplant. 2023 Jul 31;38(8):1823-1835. doi: 10.1093/ndt/gfad043.

  PMID: 36869794 DERIVED

MeSH Terms

Conditions

Renal Insufficiency; Hyperparathyroidism, Secondary; Vascular Diseases; Renal Insufficiency, Chronic; Vascular Calcification

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Angela YM Wang, MD, PhD

  University of Hong Kong, Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Associate Professor

Model Details: Cinacalcet medical treatment versus total parathyroidectomy with forearm autografting surgical treatment

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 6, 2011
• Study Start: May 10, 2010
• Primary Completion: May 22, 2017
• Study Completion: May 22, 2017
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)