Status:
TERMINATED
Treatment of Secondary Hyperparathyroidism in the Uremic Patient
Lead Sponsor:
Zealand University Hospital
Conditions:
Secondary Hyperparathyroidism
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients.
Detailed Description
Secondary hyperparathyroidism is a common feature in patients with chronic kidney disease. Its clinical consequences include renal osteodystrophy, calciphylaxia and potentially vascular calcifications...
Eligibility Criteria
Inclusion
- \>18 years old
- Secondary hyperparathyroidism; iPTH \> 350 pg/ml before any treatment or after 6 weeks without any treatment with vitamin D.
- Chronic renal insufficiency receiving hemodialysis.
- P-phosphate \< 1,8 mmol/l
- P-calcium ion \< 1,25 mmol/l
- Receiving maximal possible dose of calcium-based phosphate binder.
- Accepting 2 x 6 weeks without vitamin D.
- Safe anti conception in fertile women
- Do not expect need of calcimimetics or parathyroidectomy during the next year.
- Written informed consent.
Exclusion
- Malignancy
- Disease or condition making the patient unable to participate
- Expected lifetime less than one year.
- Pregnancy and nursing
- Allergic to contents of Zemplar or Etalpha
- Currently receiving calcimimetics
- Participating in other clinical intervention studies
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00469599
Start Date
July 1 2007
End Date
October 1 2010
Last Update
April 4 2011
Active Locations (8)
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1
Holbæk County Hospital
Holbæk, Holbæk, Denmark, 4300
2
Holstebro County Hospital
Holstebro, Holstebro, Denmark, 7500
3
Roskilde County Hospital
Roskilde, Roskilde, Denmark, 4000
4
Aalborg University Hospital
Aalborg, Denmark, 4000