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Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands

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ClinicalTrials.gov Identifier: NCT01273597
Recruitment Status : Completed
First Posted : January 10, 2011
Results First Posted : December 21, 2012
Last Update Posted : January 18, 2013
Sponsor:
Collaborator:
Planimeter Ltd
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

November 22, 2010
January 10, 2011
November 21, 2012
December 21, 2012
January 18, 2013
January 2011
November 2011   (Final data collection date for primary outcome measure)
Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection) [ Time Frame: 6 months ]
Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
To evaluate the time (in weeks) from treatment initiation to achieving maintenance dose of paricalcitol i.v. [ Time Frame: 6 months ]
Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150-300 pg/ml
Complete list of historical versions of study NCT01273597 on ClinicalTrials.gov Archive Site
  • Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6 [ Time Frame: 6 months ]
    Target intact parathyroid hormone (iPTH) values were within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
  • Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance [ Time Frame: 6 months prior to start of study through 6 months of treatment ]
    If available, data on vitamin D treatment (those who received vitamin D supplement products from Anatomical Therapeutic Chemical [ATC] group A11CC [vitamin D and analogues]) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
  • Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance [ Time Frame: 6 months prior to start of study through 6 months of treatment ]
    If available, data on the use of phosphate binders (those who received calcium-based phosphate binders or sevelamer/lanthanum) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
  • Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism [ Time Frame: 6 months prior to start of study through 6 months of treatment ]
    If available, data on the use of medication affecting secondary hyperparathyroidism (those who received calcimimetics and calcium supplementation) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
  • Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy [ Time Frame: 6 months prior to start of study through baseline ]
    Hypercalcaemia (serum calcium > 2.6 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).
  • Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment [ Time Frame: 6 months ]
    Hypercalcaemia (serum calcium > 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
  • Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy [ Time Frame: 6 months prior to start of study through baseline ]
    Hyperphosphataemia (serum phosphorus >1.78 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).
  • Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment [ Time Frame: 6 months ]
    Hyperphosphataemia (serum phosphorus > 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
  • To evaluate the proportion of patients achieving target intact parathyroid hormone (iPTH) levels (150-300 pg/ml) [ Time Frame: 6 months ]
  • To collect country-specific data on the usage of medication affecting Calcium (Ca) balance. [ Time Frame: 6 months ]
  • To collect country-specific data on the usage of medication affecting Phosphorus (P) balance. [ Time Frame: 6 months ]
  • To collect country-specific data on the usage of medication affecting secondary hyperparathyroidism. [ Time Frame: 6 months ]
  • To collect data on the incidence of hypercalcaemia during conventional vitamin D therapy. [ Time Frame: 6 months ]
  • To collect data on the incidence of hypercalcaemia during selective vitamin D receptor activator (paricalcitol) treatment. [ Time Frame: 6 months ]
  • To collect data on the incidence of hyperphosphataemia during conventional vitamin D therapy. [ Time Frame: 6 months ]
  • To collect data on the incidence of hyperphosphataemia during selective vitamin D receptor activator (paricalcitol) treatment. [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands
Post-marketing Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Paricalcitol i.v. in the Treatment of Chronic Kidney Disease (CKD) 5 Stage Patients With (Severe) Secondary Hyperparathyroidism in Hungary
This observational study will evaluate the clinical benefit of Zemplar (paricalcitol injection) in daily routine practice in end-stage renal disease patients with severe over-reactivity of parathyroid glands. Participants will be followed for 6 months. Data will be collected from participants initiated on Zemplar therapy according to standard of care. The time to achieving the maintenance dose of Zemplar (paricalcitol injection), the proportion of participants achieving target parathyroid hormone levels, and prevalence of elevated serum calcium and phosphate levels will be evaluated.
Prospective data collection started at initial dosing with Zemplar (paricalcitol injection) and ended up to 6 months later. If available, retrospective data on vitamin D treatment as well as on the incidence of hypercalcaemia and hyperphosphataemia in the 6 months leading up to paricalcitol treatment were also collected. Eight visits were planned for documentation of prospective data. In accordance with the non-interventional character of the study, only diagnostic and monitoring procedures were applied which are part of the routine medical care of secondary hyperparathyroidism.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Stage 5 chronic kidney disease patients treated in haemodialysis centers in Hungary
Kidney Failure, Chronic
Not Provided
End-stage kidney disease with secondary hyperparathyroidism
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Same as current
November 2011
November 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Based on the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection), the patient is entitled to treatment with paricalcitol injection and:

  1. ≥ 18 years of age,
  2. Willing to sign the patient information and informed consent form,
  3. Chronic kidney disease (CKD) stage 5 patient receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT), whose intact parathyroid hormone (iPTH) level is:

    • between 500-800 pg/mL with at least two abruption of conventional vitamin D therapy due to elevated serum calcium level (i.e. > 2.4 mmol/L) in the medical history, or
    • higher than 800 pg/mL and parathyroidectomy is contraindicated.
  4. The patient is planned to receive paricalcitol treatment independently from his/her participation in this study.

Exclusion Criteria:

Patients cannot be enrolled in the study if any of the following exclusion criteria apply:

  1. The patient is already treated with Zemplar (paricalcitol injection),
  2. Any contraindication exists as stated in the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection),
  3. Patients who decline to participate in the study or decline to sign the patient information/informed consent form.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
 
NCT01273597
P12-644
No
Not Provided
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Planimeter Ltd
Study Director: Tamas Schnaider AbbVie (prior sponsor, Abbott)
AbbVie
January 2013