Secondary HyperparathyroidismNCT00469599
Treatment of Secondary Hyperparathyroidism in the Uremic Patient
A study testing paricalcitol and alfacalcidol in people with Secondary Hyperparathyroidism and Chronic Kidney Disease, run by Zealand University Hospital at 8 sites in Denmark.
Trial summary
The purpose of this study is to compare alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism, Chronic Kidney Disease, Vitamin D Deficiency
- What is being tested?
- paricalcitol and alfacalcidol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 8 sitesDenmark
- Study dates
- Jul 2007to Oct 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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.
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Denmark8 sites
Aalborg University Hospital
Aalborg, 4000
Århus University Hospital Skejby
Aarhus, 4000
Hospital of Southwest Denmark Esbjerg
Esbjerg, 6700
Holbæk County Hospital
Holbæk, Holbæk, 4300
Holstebro County Hospital
Holstebro, Holstebro, 7500
Odense University Hospital
Odense, 5000
Roskilde County Hospital
Roskilde, Roskilde, 4000
Viborg County Hospital
Viborg, 8800
About this study
Official title: Treatment of Secondary Hyperparathyroidism in the Uremic Patient. A Study Comparing Alfacalcidol and Paricalcitol
The purpose of this study is to compare alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients.
Read the 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.
- Being tested
- paricalcitol, alfacalcidol
- Keywords
- Hyperparathyroidism, Secondary, Kidney Failure, Chronic, Renal Insufficiency, Chronic, Vitamin D Deficiency, Renal Osteodystrophy, Hemodialysis
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic, Vitamin D Deficiency, Kidney Failure, Chronic, Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paricalcitolDrug
Also called Zemplar
3 microg 3 times a week. dosage is increased/decreased 50 % every second week according to iPTH, ionised s-calcium and phosphate
alfacalcidolDrug
1 microg 3 times a week, dosage is titrated every second week according to iPTH, phosphate and ionised s-calcium.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | alfacalcidol 16 weeks, 6 weeks wash out, paricalcitol 16 weeks Receives: Drug: paricalcitol |
| 2 | Active comparator | paricalcitol ´16 weeks, 6 weeks wash out, alfacalcidol 16 weeks Receives: Drug: alfacalcidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of alfacalcidol and paricalcitol on intact parathyroid hormone level and the tendency towards hyperphosphatemia and hypercalcemia
Measured: 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2010 (estimated)
- Study completionOct 2010
Why it stopped: Terminated after 86 pt included, because of recruitment problems
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 Secondary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ditte Hansen, MD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469599
- Sponsor's protocol ID
- EudraCT 2006-005981-37
- Status last verified
- Apr 2011
- First submitted
- 3 May 2007
- Last updated
- 4 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25112372Hansen 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.
PubMed 19778452
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Secondary Hyperparathyroidism in the Uremic Patient. A Study Comparing Alfacalcidol and Paricalcitol
- ClinicalTrials.gov ID
- NCT00469599
- Acronym / sponsor ID
- EudraCT 2006-005981-37
- Keywords
- Hyperparathyroidism, Secondary, Kidney Failure, Chronic, Renal Insufficiency, Chronic, Vitamin D Deficiency, Renal Osteodystrophy, Hemodialysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated after 86 pt included, because of recruitment problems
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Oct 2010 (actual)
- First posted
- 4 May 2007 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: paricalcitolalfacalcidol 16 weeks, 6 weeks wash out, paricalcitol 16 weeks |
| 2 | Active comparator | Drug: alfacalcidolparicalcitol ´16 weeks, 6 weeks wash out, alfacalcidol 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- >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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| paricalcitolAlso: Zemplar3 microg 3 times a week. dosage is increased/decreased 50 % every second week according to iPTH, ionised s-calcium and phosphate | Drug | 1 |
| alfacalcidol1 microg 3 times a week, dosage is titrated every second week according to iPTH, phosphate and ionised s-calcium. | Drug | 2 |
Primary outcome
The effect of alfacalcidol and paricalcitol on intact parathyroid hormone level and the tendency towards hyperphosphatemia and hypercalcemia
Time frame: 16 weeks
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Terminated after 86 pt included, because of recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2011.
- Derived from this study: PubMed 25112372Hansen 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.
- Derived from this study: PubMed 19778452Hansen 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.
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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.
Ditte Hansen, MD principal investigator
Zealand University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paricalcitol and alfacalcidol in people with Secondary Hyperparathyroidism and Chronic Kidney Disease, run by Zealand University Hospital at 8 sites in Denmark.
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 10 inclusion and 7 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: stopped early, as of the sponsor's last update on 4 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark. 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.
Are results available for this study?
The study was stopped early (reason given: Terminated after 86 pt included, because of recruitment problems). Results are not available in the source record.
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?
The effect of alfacalcidol and paricalcitol on intact parathyroid hormone level and the tendency towards hyperphosphatemia and hypercalcemia (time frame: 16 weeks). 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 NCT00469599, 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 4 Apr 2011.