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

Secondary Hyperparathyroidism Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081665
• Other study ID #: P06-120
• Status: Completed
• Phase: N/A
• First received: February 27, 2010
• Last updated: March 26, 2012
• Start date: December 2006
• Est. completion date: February 2011

Study information

• Verified date: March 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Failure, Chronic
• Neoplasm Metastasis
• Renal Insufficiency
• Secondary Hyperparathyroidism

Locations

Country	Name	City	State
Greece	Site Reference ID/Investigator# 32049	Athens
Greece	Site Reference ID/Investigator# 32050	Athens
Greece	Site Reference ID/Investigator# 32051	Athens
Greece	Site Reference ID/Investigator# 32055	Athens
Greece	Site Reference ID/Investigator# 5283	Athens
Greece	Site Reference ID/Investigator# 32056	Chalkida
Greece	Site Reference ID/Investigator# 32057	Chania
Greece	Site Reference ID/Investigator# 32058	Drama
Greece	Site Reference ID/Investigator# 32077	Holargos
Greece	Site Reference ID/Investigator# 32076	Katerini
Greece	Site Reference ID/Investigator# 32059	Kavala
Greece	Site Reference ID/Investigator# 32053	Komotini
Greece	Site Reference ID/Investigator# 32060	Lamia
Greece	Site Reference ID/Investigator# 32061	Lefkada
Greece	Site Reference ID/Investigator# 32062	Livadia
Greece	Site Reference ID/Investigator# 32048	Pireus
Greece	Site Reference ID/Investigator# 32054	Preveza
Greece	Site Reference ID/Investigator# 32063	Ptolemaida
Greece	Site Reference ID/Investigator# 32075	Volos

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations	The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.	Baseline to Month 24 Visit	Yes
Primary	Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized	The mean (average) number of days hospitalized per participant for those hospitalized during the study.	Baseline to Month 24 Visit	Yes
Secondary	The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)	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.	Baseline to Month 24 Visit	No
Secondary	The Incidence of Clinically Significant Hypercalcemia	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.	Baseline to Month 24 Visit	Yes
Secondary	The Incidence of Clinically Significant Hyperphosphatemia	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.	Baseline to Month 24 Visit	Yes
Secondary	The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product	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.	Baseline to Month 24 Visit	Yes
Secondary	To Estimate the Incidence of (S)AEs/(S)ADRs	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.	Baseline to Month 24 Visit	Yes