Kidney FailurePhase 4PROCEEDNCT01447368
Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients
A Phase 4 study testing Cinacalcet and Surgical total parathyroidectomy with forearm autografting in people with Kidney Failure and Secondary Hyperparathyroidism, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Failure, Secondary Hyperparathyroidism, Vascular Diseases
- What is being tested?
- Cinacalcet and Surgical total parathyroidectomy with forearm autografting
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 May 2010to 22 May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Cinacalcet, Surgical total parathyroidectomy with forearm autografting
- Keywords
- chronic kidney disease, peritoneal dialysis, secondary hyperparathyroidism, parathyroidectomy, vascular calcification, cinacalcet
- Medical subject headings
- Renal Insufficiency, Hyperparathyroidism, Secondary, Vascular Diseases, Renal Insufficiency, Chronic, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinacalcetDrug
Also called Regpara
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
Surgical total parathyroidectomy with forearm autograftingProcedure or surgery
Surgical total parathyroidectomy with forearm autografting will be performed
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Cinacalcet |
| Surgical total parathyroidectomy | Active comparator | Surgical total parathyroidectomy with forearm autografting will be performed for patients randomized to this arm. Receives: Procedure: Surgical total parathyroidectomy with forearm autografting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in coronary artery calcium score
Change in coronary artery calcium score
Measured: 52 weeks
change in left ventricular mass index
change in left ventricular mass index
Measured: 52 weeks
Secondary outcomes (18)
change in left ventricular volume and ejection fraction
change in left ventricular volume and ejection fraction
Measured: 52 weeks
Change in aortic pulse wave velocity
Change in aortic pulse wave velocity
Measured: 24 and 52 weeks
Change in aortic valve and mitral valve calcium score
Change in aortic valve and mitral valve calcium score
Measured: 52 weeks
change in augmentation index and heart rate adjusted augmentation index
change in augmentation index and heart rate adjusted augmentation index
Measured: over 52 weeks
change in bone mineral density at forearm, spine and femur
change in bone mineral density at forearm, spine and femur
Measured: 52 weeks
Quality of Life (QOL) scores
Kidney Disease Outcome Quality Initiatives (KDOQI QOL domain scores)
Measured: 52 weeks
change in resting energy expenditure
Change in resting energy expenditure
Measured: 24 and 52 weeks
change in lean muscle mass
Change in lean muscle mass
Measured: 52 weeks
change in handgrip strength
Change in handgrip strength
Measured: 24 and 52 weeks
Change in subjective global assessment
Change in subjective global assessment
Measured: 24 and 52 weeks
Change in serum calcium and phosphorus
Change in biochemical parameter Serum calcium and phosphorus
Measured: over 52 weeks
change in intact parathyroid hormone (iPTH) level
Change in biochemical parameter Parathyroid hormone
Measured: 52 weeks
Change in alkaline phosphatase
Change in biochemical parameter alkaline phosphatase
Measured: over 52 weeks
change in serum albumin
CHange in biochemical parameter serum albumin
Measured: over 52 weeks
change in lymphocyte count
change in lymphocyte count
Measured: over 52 weeks
change in lipid profile
change in lipid profile
Measured: over 52 weeks
change in systolic and diastolic blood pressure
change in systolic and diastolic blood pressure
Measured: over 52 weeks
change in subendocardial viability ratio
change in subendocardial viability ratio
Measured: over 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study start10 May 2010
- Primary completion22 May 2017
- Study completion22 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cinacalcet medical treatment versus total parathyroidectomy with forearm autografting surgical treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Angela Yee-Moon Wang, The University of Hong Kong
- Investigators
- Angela YM Wang, MD, PhD, Principal investigator, University of Hong Kong, Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447368
- Sponsor's protocol ID
- CP-2015
- Acronym
- PROCEED
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2011
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38040277Wang 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.
PubMed 36869794
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01447368
- Acronym / sponsor ID
- PROCEED / CP-2015
- Keywords
- chronic kidney disease, peritoneal dialysis, secondary hyperparathyroidism, parathyroidectomy, vascular calcification, cinacalcet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 10 May 2010 (actual)
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cinacalcet medical treatment versus total parathyroidectomy with forearm autografting surgical treatment
| Arm | Type | Receives |
|---|---|---|
| Cinacalcet treatment | Experimental | Drug: CinacalcetOral 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 | Active comparator | Procedure: Surgical total parathyroidectomy with forearm autograftingSurgical total parathyroidectomy with forearm autografting will be performed for patients randomized to this arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CinacalcetAlso: Regparaoral 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 | Drug | Cinacalcet treatment |
| Surgical total parathyroidectomy with forearm autograftingSurgical total parathyroidectomy with forearm autografting will be performed | Procedure or surgery | Surgical total parathyroidectomy |
Primary outcome
Change in coronary artery calcium score
Time frame: 52 weeks
Change in coronary artery calcium score
change in left ventricular mass index
Time frame: 52 weeks
change in left ventricular mass index
18 secondary outcomes
change in left ventricular volume and ejection fraction
Time frame: 52 weeks
Change in aortic pulse wave velocity
Time frame: 24 and 52 weeks
Change in aortic valve and mitral valve calcium score
Time frame: 52 weeks
change in augmentation index and heart rate adjusted augmentation index
Time frame: over 52 weeks
change in bone mineral density at forearm, spine and femur
Time frame: 52 weeks
Quality of Life (QOL) scores
Time frame: 52 weeks
change in resting energy expenditure
Time frame: 24 and 52 weeks
change in lean muscle mass
Time frame: 52 weeks
change in handgrip strength
Time frame: 24 and 52 weeks
Change in subjective global assessment
Time frame: 24 and 52 weeks
Change in serum calcium and phosphorus
Time frame: over 52 weeks
change in intact parathyroid hormone (iPTH) level
Time frame: 52 weeks
Change in alkaline phosphatase
Time frame: over 52 weeks
change in serum albumin
Time frame: over 52 weeks
change in lymphocyte count
Time frame: over 52 weeks
change in lipid profile
Time frame: over 52 weeks
change in systolic and diastolic blood pressure
Time frame: over 52 weeks
change in subendocardial viability ratio
Time frame: over 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Derived from this study: PubMed 38040277Wang 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.
- Derived from this study: PubMed 36869794Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela YM Wang, MD, PhD principal investigator
University of Hong Kong, Queen Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cinacalcet and Surgical total parathyroidectomy with forearm autografting in people with Kidney Failure and Secondary Hyperparathyroidism, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in coronary artery calcium score (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01447368, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.