Study Stopped
Terminated after 86 pt included, because of recruitment problems
Treatment of Secondary Hyperparathyroidism in the Uremic Patient
1 other identifier
interventional
86
1 country
8
Brief Summary
The purpose of this study is to compare alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2007
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2007
CompletedFirst Posted
Study publicly available on registry
May 4, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedApril 4, 2011
April 1, 2011
3.2 years
May 3, 2007
April 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effect of alfacalcidol and paricalcitol on intact parathyroid hormone level and the tendency towards hyperphosphatemia and hypercalcemia
16 weeks
Secondary Outcomes (1)
alkaline phosphatase, 25OH-vitamin D,1,25 OH2-vitamin D,calcium x phosphate product, blood pressure, pulse, pulse pressure, parathyroidectomy, pulse wave velocity and pulse wave analysis, initiation of treatment with calcimimetics.
16 weeks
Study Arms (2)
1
ACTIVE COMPARATORalfacalcidol 16 weeks, 6 weeks wash out, paricalcitol 16 weeks
2
ACTIVE COMPARATORparicalcitol ´16 weeks, 6 weeks wash out, alfacalcidol 16 weeks
Interventions
3 microg 3 times a week. dosage is increased/decreased 50 % every second week according to iPTH, ionised s-calcium and phosphate
1 microg 3 times a week, dosage is titrated every second week according to iPTH, phosphate and ionised s-calcium.
Eligibility Criteria
You may qualify if:
- \>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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Holbæk County Hospital
Holbæk, Holbæk, 4300, Denmark
Holstebro County Hospital
Holstebro, Holstebro, 7500, Denmark
Roskilde County Hospital
Roskilde, Roskilde, 4000, Denmark
Aalborg University Hospital
Aalborg, 4000, Denmark
Århus University Hospital Skejby
Aarhus, 4000, Denmark
Hospital of Southwest Denmark Esbjerg
Esbjerg, 6700, Denmark
Odense University Hospital
Odense, 5000, Denmark
Viborg County Hospital
Viborg, 8800, Denmark
Related Publications (2)
Hansen D, Rasmussen K, Rasmussen LM, Bruunsgaard H, Brandi L. The influence of vitamin D analogs on calcification modulators, N-terminal pro-B-type natriuretic peptide and inflammatory markers in hemodialysis patients: a randomized crossover study. BMC Nephrol. 2014 Aug 12;15:130. doi: 10.1186/1471-2369-15-130.
PMID: 25112372DERIVEDHansen D, Brandi L, Rasmussen K. Treatment of secondary hyperparathyroidism in haemodialysis patients: a randomised clinical trial comparing paricalcitol and alfacalcidol. BMC Nephrol. 2009 Sep 24;10:28. doi: 10.1186/1471-2369-10-28.
PMID: 19778452DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ditte Hansen, MD
Zealand University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 3, 2007
First Posted
May 4, 2007
Study Start
July 1, 2007
Primary Completion
September 1, 2010
Study Completion
October 1, 2010
Last Updated
April 4, 2011
Record last verified: 2011-04