Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation

Secondary Hyperparathyroidism Clinical Trial

Official title:

Prospective, Open-label, Multicenter Effectiveness and Safety Observational Study of Zemplar in Patients With Stage 5 Chronic Kidney Disease and Hyperparathyroidism on Hemodialysis in the Russian Federation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401478
• Other study ID #: P12-838
• Status: Completed
• Phase: N/A
• First received: July 22, 2011
• Last updated: February 28, 2014
• Start date: July 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Observational

Clinical Trial Summary

Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Planned therapy will be six months. Participants with Stage 5 Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into the study. Ability of Zemplar, (paricalcitol) to lower intact Parathyroid Hormone level will be assessed during the study.

Description:

Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Study drug will be administered per local prescribing guidelines. Planned therapy is six months. Intact Parathyroid Hormone will be measured at the Screening visit. All participants who meet the inclusion criteria and fail to meet the exclusion criteria will be included in the study.

Adverse events will be monitored throughout the observation period (and up to 30 days after the last dose of Zemplar).

Ability of Zemplar to lower intact Parathyroid Hormone level will be assessed throughout the study. Proportion of participants with the level of intact Parathyroid Hormone 150 - 300 pg/mL was stated as primary endpoint. Calcium and Phosphorus elevation will be also measured throughout the study.

The selected population is representative in relation to those who will take Zemplar in routine practice. Participants with contraindications to Zemplar therapy (as per the local label) will not be included in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 18-65 years

2. Chronic Kidney Disease stage 5 receiving hemodialysis

3. Authorization (Consent) for Use/Disclosure of Data signed by the patient

4. Planned prescription of Zemplar treatment due to fair clinical need and irrespectively of the participation in the current program according to the local label within 2 weeks after screening into the program

5. Screening intact Parathyroid Hormone level (measured not earlier than 1 month before first dose of Zemplar) between 300 and 900 pg/mL

Exclusion Criteria:

1. Contraindications to Zemplar as indicated in approved label, including but not limited to hypersensitivity, hypervitaminosis D (serum D3 level above 32 ng/mL), concomitant use of vitamin D or phosphates, lactation period, pregnancy

2. Any experimental drug within the period of 30 days before the inclusion into the program

3. Screening Ca x P > 65 mg^2/dL^2

4. Screening normalized serum total calcium > 10.2 mg/dL

5. Necessity for calcitonin maintenance oral or intravenous glucocorticoids, or other drugs that could have affected calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Locations

Country	Name	City	State
Russian Federation	Site Reference ID/Investigator# 57348	Almetyevsk
Russian Federation	Site Reference ID/Investigator# 57347	Cheboksary
Russian Federation	Site Reference ID/Investigator# 58347	Chelyabinsk
Russian Federation	Site Reference ID/Investigator# 67404	Iakutsk
Russian Federation	Site Reference ID/Investigator# 57344	Irkutsk
Russian Federation	Site Reference ID/Investigator# 57346	Kazan
Russian Federation	Site Reference ID/Investigator# 58348	Moscow
Russian Federation	Site Reference ID/Investigator# 58356	Moscow
Russian Federation	Site Reference ID/Investigator# 57342	Novosibirsk
Russian Federation	Site Reference ID/Investigator# 57364	Orenburg
Russian Federation	Site Reference ID/Investigator# 69687	Samara
Russian Federation	Site Reference ID/Investigator# 57363	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 69688	Ulan-Ude

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	Almedis

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study	The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded.	6 months	No
Secondary	Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study	The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded.	6 months	No
Secondary	Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study	The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded.	6 months	No
Secondary	Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg^2/dL^2) Levels at Least Once Post-baseline During the Study	The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg^2/dL^2) levels at least once post-baseline during the study was recorded.	6 months	Yes
Secondary	Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg^2/dL^2) Levels at Each Visit Post-baseline During the Study	The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg^2/dL^2) levels at each visit post-baseline during the study was recorded.	6 months	Yes
Secondary	Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study	The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at least once post-baseline during the study was recorded.	6 months	Yes
Secondary	Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study	The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at each visit post-baseline during the study was recorded.	6 months	Yes
Secondary	Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination	The percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded.; Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks.	6 months	Yes

External Links

•   Link