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Parathyroidectomy versus cinacalcet for the correction of secondary hyperparathyroidism in hemodialysis patients

Parathyroidectomy versus cinacalcet for the correction of secondary hyperparathyroidism in hemodialysis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29506
Enrollment
128
Registered
2015-08-25
Start date
2016-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The use of Cinacalcet in secondary hyperparathyroidism and chronic renal failure instead of Total parathyroidectomy

Interventions

Total parathyroidectomy with transplantation versus the use of Cinacalcet

Sponsors

Kruijff S, Groningen, The Netherlands Hanzeplein 1a , Surgical department s.kruijff@umcg.nl
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Age > 18 years - Newly diagnosed sHPT, defined as PTH level >9x ULN -Hemodialysis or peritoneal dialysis patients -> 3 months of chronic dialysis - Signed informed consent

Exclusion criteria

Exclusion criteria: -Cinacalcet use within the past 3 months -Former renal transplant -Former parathyroidectomy -Former dialysis -Malignancy in history

Design outcomes

Primary

MeasureTime frame
PTH 3 months after the intervention

Secondary

MeasureTime frame
- cardiovascular events (myocardial infarction, peripheral vascular disease, instable angina, cerebrovascular disease, CVA, TIA), arrhythmias) - Costs - phosphorus, calcium - fibroblast growth factor 23 levels - renal function - all-cause mortality

Contacts

Public ContactSchelto Kruijff

Hanzeplein 1a UMCG

s.kruijff@umcg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)