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NCT Number: NCT01081665

Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism

The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Greece.

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Key information

Conditions

Chronic Kidney Failure Chronic Disease Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Secondary Hyperparathyroidism Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 32049, Athens, Greece

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About this study

The primary objective of this study is to evaluate the safety of Zemplar® in the treatment of Secondary hyperparathyroidism (iParathormone>300 pg/mL) in subjects on hemodialysis treated in conditions of usual clinical care.

The primary safety endpoints of this study are to evaluate the safety of Zemplar by recording the number of hospitalizations and days hospitalized.

A secondary efficacy endpoint will be the proportion of subjects achieving therapeutic success. Therapeutic success with Zemplar® will be defined as:

  • 40% reduction in the base iPTH level is achieved, and/or;
  • serum iParathormone level < 300 pg/mL.

Additional secondary endpoints are the incidence (proportion of patients) of clinically meaningful hypercalcemia (defined as corrected serum calcium (Ca) > 11.0 mg/dL taken at 2 consecutive measurements), hyperphosphatemia (defined as serum phosphorous (P)>6.5 mg/dL taken at 2 consecutive measurements), and elevated Ca x P product (defined as serum Ca x P>65 mg^2/dL^2 taken at 2 consecutive measurements). Safety also will be assessed through adverse event monitoring and evaluation of laboratory variables and vital signs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is >= 18 years of age and diagnosed with secondary hyperparathyroidism and a pretreatment iParathormone > 300 pg/mL.
  • Subject is receiving chronic hemodialysis.
  • Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.
  • Subject has provided their informed consent to participate.

Exclusion criteria

  • Subject has a corrected serum calcium > 10.5 mg/dL, serum phosphorus >= 6.5 mg/dL or subjects with corrected Ca x P >= 65 mg^2/dl^2.
  • Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients.
  • Subject has participated in clinical study within the last month.
  • Zemplar is contraindicated according to the Summary of Product Characteristics.

Treatment and study plan

Primary outcomes

  1. Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations

    Time frame: Baseline to Month 24 Visit

    The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.

  2. Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized

    Time frame: Baseline to Month 24 Visit

    The mean (average) number of days hospitalized per participant for those hospitalized during the study.

Secondary outcomes

  1. The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)

    Time frame: Baseline to Month 24 Visit

    Therapeutic success of paricalcitol treatment was defined as a 40% decrease from the baseline measurement in the level of intact parathyroid hormone (also known as iPTH or parathormone) and/or a serum intact parathyroid hormone level less than 300 picograms per milliliter (pg/mL) for at least 2 consecutive available measurements during the 24-month follow-up period.

  2. The Incidence of Clinically Significant Hypercalcemia

    Time frame: Baseline to Month 24 Visit

    The number of participants with clinically significant hypercalcemia (too much calcium in the blood), defined as a corrected serum calcium level greater than 11.0 milligrams per deciliter (mg/dL) at 2 consecutive measurements.

  3. The Incidence of Clinically Significant Hyperphosphatemia

    Time frame: Baseline to Month 24 Visit

    The number of participants with clinically significant hyperphosphatemia (too much phosphorous in the blood), defined as serum phosphorous levels greater than 6.5 milligrams per deciliter (mg/dL) at 2 consecutive measurements.

  4. The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product

    Time frame: Baseline to Month 24 Visit

    The number of participants with clinically significant levels of calcium-phosphorous product (Ca x P), defined as serum calcium-phosphorous product levels greater than 65 milligrams squared per deciliters squared (mg^2/dL^2) at 2 consecutive measurements.

  5. To Estimate the Incidence of (S)AEs/(S)ADRs

    Time frame: Baseline to Month 24 Visit

    The number of adverse events, serious adverse events (including death), adverse drug reactions, and serious adverse drug reactions experienced by participants during the study are summarized. Adverse events include any events reported regardless of whether or not they were considered related to the study drug. Adverse drug reactions include events where a causal relationship between the drug and the occurence of the event is suspected. For additional details see the Reported Adverse Events section.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Two-year, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Haemodialysis, Receiving Zemplar for Prevention and Treatment of Secondary Hyperparathyroidism

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Mar 5, 2010
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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