Trial Outcomes & Findings for 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 (NCT NCT01273597)

Last Updated: 2013-01-18

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

60 participants

Primary outcome timeframe

6 months

Results posted on

2013-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	End-stage Kidney Disease With Secondary Hyperparathyroidism Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Overall Study STARTED	60
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	End-stage Kidney Disease With Secondary Hyperparathyroidism Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Overall Study Adverse Event	5
Overall Study Underwent Kidney Transplantation	2
Overall Study Reason Not Reported	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	End-stage Kidney Disease With Secondary Hyperparathyroidism n=60 Participants Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Age Continuous	57.7 years n=99 Participants
Sex: Female, Male Female	31 Participants n=99 Participants
Sex: Female, Male Male	29 Participants n=99 Participants
Region of Enrollment Hungary	60 participants n=99 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Participants who achieved maintenance dose of Zemplar (paricalcitol injection)

Outcome measures

Outcome measures
Measure	End-stage Kidney Disease With Secondary Hyperparathyroidism n=16 Participants Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)	12.2 weeks Standard Deviation 7.6

SECONDARY outcome

Timeframe: 6 months

Population: All participants

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.

Outcome measures

Outcome measures
Measure	End-stage Kidney Disease With Secondary Hyperparathyroidism n=60 Participants Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6	14 participants

SECONDARY outcome

Timeframe: 6 months prior to start of study through 6 months of treatment

Population: This outcome measure was not analyzed due to lack of data.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months prior to start of study through 6 months of treatment

Population: This outcome measure was not analyzed due to lack of data.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months prior to start of study through 6 months of treatment

Population: This outcome measure was not analyzed due to lack of data.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months prior to start of study through baseline

Population: Participants with available retrospective data

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).

Outcome measures

Outcome measures
Measure	End-stage Kidney Disease With Secondary Hyperparathyroidism n=58 Participants Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy	5 participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants with available retrospective data (cohort analyzed for Outcome Measure 6) were analyzed prospectively at Month 6 of treatment.

Hypercalcaemia (serum calcium \> 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).

Outcome measures

Outcome measures
Measure	End-stage Kidney Disease With Secondary Hyperparathyroidism n=58 Participants Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment	20 participants

SECONDARY outcome

Timeframe: 6 months prior to start of study through baseline

Population: Participants with available retrospective data

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).

Outcome measures

Outcome measures
Measure	End-stage Kidney Disease With Secondary Hyperparathyroidism n=54 Participants Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy	39 participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants with available retrospective data (cohort analyzed for Outcome Measure 8) were analyzed prospectively at Month 6 of treatment.

Hyperphosphataemia (serum phosphorus \> 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).

Outcome measures

Outcome measures
Measure	End-stage Kidney Disease With Secondary Hyperparathyroidism n=54 Participants Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment	50 participants

Adverse Events

End-stage Kidney Disease With Secondary Hyperparathyroidism

Serious events: 9 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	End-stage Kidney Disease With Secondary Hyperparathyroidism n=60 participants at risk Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Blood and lymphatic system disorders Anaemia	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Cardiac disorders Atrial fibrillation	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Gastrointestinal disorders Duodenal ulcer haemorrhage	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Gastrointestinal disorders Gastric ulcer haemorrhage	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
General disorders Inflammation	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
General disorders Pyrexia	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
General disorders Spinal pain	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Infections and infestations Abscess limb	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Infections and infestations Arthritis bacterial	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
General disorders Bronchitis	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Infections and infestations Erysipelas	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Infections and infestations Gangrene	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Infections and infestations Pneumonia	3.3% 2/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Infections and infestations Sepsis	3.3% 2/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Infections and infestations Staphylococcal bacteraemia	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Infections and infestations Staphylococcal sepsis	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Musculoskeletal and connective tissue disorders Sacroiliitis	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	3.3% 2/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Nervous system disorders Cerebrovascular accident	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Nervous system disorders Ischaemic stroke	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Respiratory, thoracic and mediastinal disorders Pneumonia	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Skin and subcutaneous tissue disorders Skin lesion	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Vascular disorders Arterial occlusive disease	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Vascular disorders Circulatory collapse	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Vascular disorders Hypertension	1.7% 1/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.

Other adverse events

Other adverse events
Measure	End-stage Kidney Disease With Secondary Hyperparathyroidism n=60 participants at risk Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Investigations Calcium phosphate product increased	8.3% 5/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Metabolism and nutrition disorders Hypercalcaemia	11.7% 7/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Metabolism and nutrition disorders Hyperphoshataemia	6.7% 4/60 • Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER