Treatment of Secondary Hyperparathyroidism in the Uremic Patient

This study has been terminated.
(Terminated after 86 pt included, because of recruitment problems)
Sponsor:
Information provided by:
Roskilde County Hospital
ClinicalTrials.gov Identifier:
NCT00469599
First received: May 3, 2007
Last updated: April 1, 2011
Last verified: April 2011
  Purpose

The purpose of this study is to compare alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients.


Condition Intervention
Secondary Hyperparathyroidism
Chronic Kidney Disease
Vitamin D Deficiency
Drug: paricalcitol
Drug: alfacalcidol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Secondary Hyperparathyroidism in the Uremic Patient. A Study Comparing Alfacalcidol and Paricalcitol

Resource links provided by NLM:


Further study details as provided by Roskilde County Hospital:

Primary Outcome Measures:
  • The effect of alfacalcidol and paricalcitol on intact parathyroid hormone level and the tendency towards hyperphosphatemia and hypercalcemia [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 86
Study Start Date: July 2007
Study Completion Date: October 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
alfacalcidol 16 weeks, 6 weeks wash out, paricalcitol 16 weeks
Drug: paricalcitol
3 microg 3 times a week. dosage is increased/decreased 50 % every second week according to iPTH, ionised s-calcium and phosphate
Other Name: Zemplar
Active Comparator: 2
paricalcitol ´16 weeks, 6 weeks wash out, alfacalcidol 16 weeks
Drug: alfacalcidol
1 microg 3 times a week, dosage is titrated every second week according to iPTH, phosphate and ionised s-calcium.
Other Name: alfacalcidol

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. >18 years old
  2. Secondary hyperparathyroidism; iPTH > 350 pg/ml before any treatment or after 6 weeks without any treatment with vitamin D.
  3. Chronic renal insufficiency receiving hemodialysis.
  4. P-phosphate < 1,8 mmol/l
  5. P-calcium ion < 1,25 mmol/l
  6. Receiving maximal possible dose of calcium-based phosphate binder.
  7. Accepting 2 x 6 weeks without vitamin D.
  8. Safe anti conception in fertile women
  9. Do not expect need of calcimimetics or parathyroidectomy during the next year.
  10. Written informed consent.

Exclusion Criteria:

  1. Malignancy
  2. Disease or condition making the patient unable to participate
  3. Expected lifetime less than one year.
  4. Pregnancy and nursing
  5. Allergic to contents of Zemplar or Etalpha
  6. Currently receiving calcimimetics
  7. Participating in other clinical intervention studies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469599

Locations
Denmark
Aalborg University Hospital
Aalborg, Denmark, 4000
Århus University Hospital Skejby
Aarhus, Denmark, 4000
Hospital of Southwest Denmark Esbjerg
Esbjerg, Denmark, 6700
Holbæk County Hospital
Holbæk, Denmark, 4300
Holstebro County Hospital
Holstebro, Denmark, 7500
Odense University Hospital
Odense, Denmark, 5000
Roskilde County Hospital
Roskilde, Denmark, 4000
Viborg County Hospital
Viborg, Denmark, 8800
Sponsors and Collaborators
Roskilde County Hospital
Investigators
Principal Investigator: Ditte Hansen, MD Roskilde County Hospital
  More Information

No publications provided by Roskilde County Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ditte Hansen MD, Roskilde County Hospital
ClinicalTrials.gov Identifier: NCT00469599     History of Changes
Other Study ID Numbers: EudraCT 2006-005981-37
Study First Received: May 3, 2007
Last Updated: April 1, 2011
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Roskilde County Hospital:
Hyperparathyroidism, Secondary
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Vitamin D Deficiency
Renal Osteodystrophy
Hemodialysis

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Vitamin D Deficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Renal Insufficiency
Hydroxycholecalciferols
Ergocalciferols
1-hydroxycholecalciferol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 15, 2014