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Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients (PROCEED)

Primary Purpose

Kidney Failure, Secondary Hyperparathyroidism, Vascular Diseases

Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Cinacalcet
Surgical total parathyroidectomy with forearm autografting
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure focused on measuring chronic kidney disease, peritoneal dialysis, secondary hyperparathyroidism, parathyroidectomy, vascular calcification, cinacalcet

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Queen Mary Hospital and Tung Wah Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cinacalcet treatment

Surgical total parathyroidectomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in coronary artery calcium score
Change in coronary artery calcium score
change in left ventricular mass index
change in left ventricular mass index

Secondary Outcome Measures

change in left ventricular volume and ejection fraction
change in left ventricular volume and ejection fraction
Change in aortic pulse wave velocity
Change in aortic pulse wave velocity
Change in aortic valve and mitral valve calcium score
Change in aortic valve and mitral valve calcium score
change in augmentation index and heart rate adjusted augmentation index
change in augmentation index and heart rate adjusted augmentation index
change in bone mineral density at forearm, spine and femur
change in bone mineral density at forearm, spine and femur
Quality of Life (QOL) scores
Kidney Disease Outcome Quality Initiatives (KDOQI QOL domain scores)
change in resting energy expenditure
Change in resting energy expenditure
change in lean muscle mass
Change in lean muscle mass
change in handgrip strength
Change in handgrip strength
Change in subjective global assessment
Change in subjective global assessment
Change in serum calcium and phosphorus
Change in biochemical parameter Serum calcium and phosphorus
change in intact parathyroid hormone (iPTH) level
Change in biochemical parameter Parathyroid hormone
Change in alkaline phosphatase
Change in biochemical parameter alkaline phosphatase
change in serum albumin
CHange in biochemical parameter serum albumin
change in lymphocyte count
change in lymphocyte count
change in lipid profile
change in lipid profile
change in systolic and diastolic blood pressure
change in systolic and diastolic blood pressure
change in subendocardial viability ratio
change in subendocardial viability ratio

Full Information

First Posted
October 4, 2011
Last Updated
October 4, 2021
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01447368
Brief Title
Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients
Acronym
PROCEED
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 10, 2010 (Actual)
Primary Completion Date
May 22, 2017 (Actual)
Study Completion Date
May 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Secondary Hyperparathyroidism, Vascular Diseases
Keywords
chronic kidney disease, peritoneal dialysis, secondary hyperparathyroidism, parathyroidectomy, vascular calcification, cinacalcet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Cinacalcet medical treatment versus total parathyroidectomy with forearm autografting surgical treatment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cinacalcet treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Surgical total parathyroidectomy
Arm Type
Active Comparator
Arm Description
Surgical total parathyroidectomy with forearm autografting will be performed for patients randomized to this arm.
Intervention Type
Drug
Intervention Name(s)
Cinacalcet
Other Intervention Name(s)
Regpara
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Surgical total parathyroidectomy with forearm autografting
Intervention Description
Surgical total parathyroidectomy with forearm autografting will be performed
Primary Outcome Measure Information:
Title
Change in coronary artery calcium score
Description
Change in coronary artery calcium score
Time Frame
52 weeks
Title
change in left ventricular mass index
Description
change in left ventricular mass index
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
change in left ventricular volume and ejection fraction
Description
change in left ventricular volume and ejection fraction
Time Frame
52 weeks
Title
Change in aortic pulse wave velocity
Description
Change in aortic pulse wave velocity
Time Frame
24 and 52 weeks
Title
Change in aortic valve and mitral valve calcium score
Description
Change in aortic valve and mitral valve calcium score
Time Frame
52 weeks
Title
change in augmentation index and heart rate adjusted augmentation index
Description
change in augmentation index and heart rate adjusted augmentation index
Time Frame
over 52 weeks
Title
change in bone mineral density at forearm, spine and femur
Description
change in bone mineral density at forearm, spine and femur
Time Frame
52 weeks
Title
Quality of Life (QOL) scores
Description
Kidney Disease Outcome Quality Initiatives (KDOQI QOL domain scores)
Time Frame
52 weeks
Title
change in resting energy expenditure
Description
Change in resting energy expenditure
Time Frame
24 and 52 weeks
Title
change in lean muscle mass
Description
Change in lean muscle mass
Time Frame
52 weeks
Title
change in handgrip strength
Description
Change in handgrip strength
Time Frame
24 and 52 weeks
Title
Change in subjective global assessment
Description
Change in subjective global assessment
Time Frame
24 and 52 weeks
Title
Change in serum calcium and phosphorus
Description
Change in biochemical parameter Serum calcium and phosphorus
Time Frame
over 52 weeks
Title
change in intact parathyroid hormone (iPTH) level
Description
Change in biochemical parameter Parathyroid hormone
Time Frame
52 weeks
Title
Change in alkaline phosphatase
Description
Change in biochemical parameter alkaline phosphatase
Time Frame
over 52 weeks
Title
change in serum albumin
Description
CHange in biochemical parameter serum albumin
Time Frame
over 52 weeks
Title
change in lymphocyte count
Description
change in lymphocyte count
Time Frame
over 52 weeks
Title
change in lipid profile
Description
change in lipid profile
Time Frame
over 52 weeks
Title
change in systolic and diastolic blood pressure
Description
change in systolic and diastolic blood pressure
Time Frame
over 52 weeks
Title
change in subendocardial viability ratio
Description
change in subendocardial viability ratio
Time Frame
over 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela YM Wang, MD, PhD
Organizational Affiliation
University of Hong Kong, Queen Mary Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital and Tung Wah Hospital
City
Hong Kong
ZIP/Postal Code
0000
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

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