Treatment of Secondary Hyperparathyroidism in the Uremic Patient
Primary Purpose
Secondary Hyperparathyroidism, Chronic Kidney Disease, Vitamin D Deficiency
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
paricalcitol
alfacalcidol
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Hyperparathyroidism, Secondary, Kidney Failure, Chronic, Renal Insufficiency, Chronic, Vitamin D Deficiency, Renal Osteodystrophy, Hemodialysis
Eligibility Criteria
Inclusion Criteria:
- >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 Criteria:
- 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
Sites / Locations
- Aalborg University Hospital
- Århus University Hospital Skejby
- Hospital of Southwest Denmark Esbjerg
- Holbæk County Hospital
- Holstebro County Hospital
- Odense University Hospital
- Roskilde County Hospital
- Viborg County Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
alfacalcidol 16 weeks, 6 weeks wash out, paricalcitol 16 weeks
paricalcitol ´16 weeks, 6 weeks wash out, alfacalcidol 16 weeks
Outcomes
Primary Outcome Measures
The effect of alfacalcidol and paricalcitol on intact parathyroid hormone level and the tendency towards hyperphosphatemia and hypercalcemia
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00469599
Brief Title
Treatment of Secondary Hyperparathyroidism in the Uremic Patient
Official Title
Treatment of Secondary Hyperparathyroidism in the Uremic Patient. A Study Comparing Alfacalcidol and Paricalcitol
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Terminated
Why Stopped
Terminated after 86 pt included, because of recruitment problems
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Zealand University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 with increased morbidity and mortality.
Reduced synthesis of active vitamin D contributes to secondary hyperparathyroidism. Therefore we primarily manage this condition with activated vitamin D. In Denmark alfacalcidol is the primary choice of vitamin D analog.
However hypercalcemia and hyperphosphatemia may limit the use of alfacalcidol therapy due to increased risk of vascular calcification and mortality.
Therefore a new vitamin D analog, paricalcitol, has been developed, that may be less prone to develop hypercalcemia and hyperphosphatemia.
However a randomised controlled clinical study comparing alfacalcidol and paricalcitol has never been performed.
The primary objective of this study is to evaluate the effect of alfacalcidol and paricalcitol on intact parathyroid hormone level and the tendency towards hyperphosphatemia and hypercalcemia.
The study is performed in 117 patients with end stage renal failure on maintenance hemodialysis therapy in 6 different Danish hemodialysis units.
The design is a multicenter crossover study where patients are randomized into two treatment arms. After a wash out period of 6 weeks they are receiving alfacalcidol or paricalcitol for a period of 16 weeks and after a further wash out period of 6 weeks they receive the contrary treatment (respectively paricalcitol or alfacalcidol) for 16 weeks.
The initial dose of alfacalcidol (1 μg intravenously after dialysis) and paricalcitol (3 μg intravenously after dialysis) will be adjusted every second week based on iPTH, p-calcium and p-phosphate.
P-calcium, p-phosphate, iPTH, pulse and blood pressure are measured every second week. By the beginning and the end of each period of treatment, alkaline phosphatase, 25OH-D3, 1,25 (OH)2 vitamin D and safety parameters are measured, pulse wave velocity and pulse wave analysis is performed in a subgroup.
Alfacalcidol and paricalcitol are both registered treatment modalities for patients with renal failure and secondary hyperparathyroidism and should not perform any risk for the safety of the enrolled patients as well as the blood sampling and blood pressure measurement should not perform any risk either.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, Chronic Kidney Disease, Vitamin D Deficiency
Keywords
Hyperparathyroidism, Secondary, Kidney Failure, Chronic, Renal Insufficiency, Chronic, Vitamin D Deficiency, Renal Osteodystrophy, Hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
alfacalcidol 16 weeks, 6 weeks wash out, paricalcitol 16 weeks
Arm Title
2
Arm Type
Active Comparator
Arm Description
paricalcitol ´16 weeks, 6 weeks wash out, alfacalcidol 16 weeks
Intervention Type
Drug
Intervention Name(s)
paricalcitol
Other Intervention Name(s)
Zemplar
Intervention Description
3 microg 3 times a week. dosage is increased/decreased 50 % every second week according to iPTH, ionised s-calcium and phosphate
Intervention Type
Drug
Intervention Name(s)
alfacalcidol
Intervention Description
1 microg 3 times a week, dosage is titrated every second week according to iPTH, phosphate and ionised s-calcium.
Primary Outcome Measure Information:
Title
The effect of alfacalcidol and paricalcitol on intact parathyroid hormone level and the tendency towards hyperphosphatemia and hypercalcemia
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ditte Hansen, MD
Organizational Affiliation
Zealand University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Århus University Hospital Skejby
City
Aarhus
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Hospital of Southwest Denmark Esbjerg
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Holbæk County Hospital
City
Holbæk
ZIP/Postal Code
4300
Country
Denmark
Facility Name
Holstebro County Hospital
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Roskilde County Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Viborg County Hospital
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
25112372
Citation
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.
Results Reference
derived
PubMed Identifier
19778452
Citation
Hansen 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.
Results Reference
derived
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Treatment of Secondary Hyperparathyroidism in the Uremic Patient
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