Trial Outcomes & Findings for Study to Assess Patient Management Practices and Quality of Life With Paricalcitol Capsules in the Treatment of Secondary Hyperparathyroidism in Stage 3-5 Chronic Kidney Disease Patients Not Yet on Dialysis (NCT NCT01265992)

NCT ID: NCT01265992

Last Updated: 2014-02-19

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 50 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2014-02-19

Participant Flow

Participant milestones

Measure	Paricalcitol Capsules Patients with secondary hyperparathyroidism associated with Stage 3 - 5 chronic kidney disease (CKD) and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Overall Study STARTED	50
Overall Study Received Treatment	49
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Paricalcitol Capsules Patients with secondary hyperparathyroidism associated with Stage 3 - 5 chronic kidney disease (CKD) and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	1
Overall Study Administrative reasons	2
Overall Study Stopped treatment	3
Overall Study Did not receive treatment	1

Baseline Characteristics

Study to Assess Patient Management Practices and Quality of Life With Paricalcitol Capsules in the Treatment of Secondary Hyperparathyroidism in Stage 3-5 Chronic Kidney Disease Patients Not Yet on Dialysis

Baseline characteristics by cohort

Measure	Paricalcitol Capsules n=49 Participants Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Age, Continuous	63.7 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Race/Ethnicity, Customized White	49 participants n=5 Participants
Race/Ethnicity, Customized Black	0 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants
Race/Ethnicity, Customized American (Indian/Alaska Native)	0 participants n=5 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants
Region of Enrollment Sweden	49 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Per-Protocol Analysis Set (PPAS), defined as all included participants who received at least 1 dose of paricalcitol capsules and had analyzable data for the primary endpoints, i.e., 5 - 8 months after inclusion, and with available iPTH data at both time points.

Outcome measures

Measure	Paricalcitol Capsules n=36 Participants Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Change From Baseline in Intact Parathyroid Hormone at 6 Months	-6.2 pmol/L Standard Deviation 13.0

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Per-protocol analysis set. Three participants had missing data at Baseline and one participant had missing data at the 6 month visit; percentages are based on the total number of participants in the per-protocol analysis set (40).

Kidney Disease Outcomes Quality Initiative (K/DOQI) target intact parathyroid hormone (iPTH) levels are:

Stage 3 CKD (estimated Glomerular Filtration Rate* [eGFR] 30 - 59 mL/min): 3.85 - 7.7 pmol/L;

Stage 4 CKD (eGFR 15 - 29 mL/min): 7.7 - 12.1 pmol/L;

Stage 5 CKD (eGFR < 15 mL/min): 16.5 - 33 pmol/L.

*Calculated using the Modification of Diet in Renal Disease formula.

Outcome measures

Measure	Paricalcitol Capsules n=40 Participants Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months Baseline	15.0 percentage of participants
Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months 6 months	27.5 percentage of participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Per-protocol analysis set. Two patients had missing s-P data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40).

Elevated serum phosphorus is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions as:

Stage 3 CKD: ≥ 1.49 mmol/L;

Stage 4 CKD: ≥ 1.49 mmol/L;

Stage 5 CKD: > 1.78 mmol/L.

Outcome measures

Measure	Paricalcitol Capsules n=40 Participants Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months Baseline	15.0 percentage of participants
Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months 6 months	25.0 percentage of participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Per-protocol analysis set. One participant had missing s-Ca data at Baseline and one participant had missing s-Ca data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40).

Elevated serum calcium is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions of s-Ca above 2.37 mmol/L.

Outcome measures

Measure	Paricalcitol Capsules n=40 Participants Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months Baseline	42.5 percentage of participants
Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months 6 months	42.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: Per-protocol analysis set with available data at both time points.

Proteinuria is the presence of excess serum proteins, or albumin, in the urine. Proteinuria was measured by the amount of albumin per liter of urine.

Outcome measures

Measure	Paricalcitol Capsules n=10 Participants Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Change From Baseline in Proteinuria	0.2 g/L Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Per-protocol analysis set. Percentages are based on the total number of participants in the per-protocol analysis set.

Outcome measures

Measure	Paricalcitol Capsules n=40 Participants Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline	10.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Per-protocol analysis set with available data at both time points.

The KDQOL-SF is a self-report measure developed for individuals with kidney disease. It includes 43 end-stage renal disease (ESRD)-targeted items focused on particular areas of concern for individuals with kidney disease (Symptoms/problems, Effects of the disease on daily life, Burden of disease, Work status, Cognitive function, Quality of social interaction, Sexual function, Sleep, and Social support), 36 items (SF-36) that provide 8 measures of physical and mental health (Physical functioning, Role limitations caused by physical health limitations, Role limitations caused by emotional health problems, Social functioning, Emotional well-being, Pain, Energy/fatigue and General health perceptions), and 1 overall health rating item where respondents rate their health on a scale from 0 ("worst possible health") to 10 ("best possible health").

Scores are transformed and calculated such that each scale score ranges from 0 to 100 where higher scores reflect a better quality of life.

Outcome measures

Measure	Paricalcitol Capsules n=24 Participants Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) ESRD: Symptom/problem scale	-0.4 units on a scale Standard Deviation 12.9
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) ESRD: Effects of kidney disease	-0.2 units on a scale Standard Deviation 9.4
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) ESRD: Burden of kidney disease	-1.0 units on a scale Standard Deviation 19.5
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) ESRD: Work status	-10.4 units on a scale Standard Deviation 29.4
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) ESRD: Cognitive function	-2.5 units on a scale Standard Deviation 19.7
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) ESRD: Quality of social interaction	1.7 units on a scale Standard Deviation 20.3
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) ESRD: Sexual function	-0.6 units on a scale Standard Deviation 23.0
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) ESRD: Sleep	0.9 units on a scale Standard Deviation 11.3
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) ESRD: Social Support	-4.9 units on a scale Standard Deviation 17.4
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) SF-36: Physical functioning	5.7 units on a scale Standard Deviation 18.6
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) SF-36: Role physical	-7.3 units on a scale Standard Deviation 36.5
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) SF-36: Pain	-2.3 units on a scale Standard Deviation 22.1
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) SF-36: General health	1.5 units on a scale Standard Deviation 16.6
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) SF-36: Emotional well-being	-3.0 units on a scale Standard Deviation 13.4
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) SF-36: Role emotional	-11.1 units on a scale Standard Deviation 36.3
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) SF-36: Social function	0.5 units on a scale Standard Deviation 22.0
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) SF-36: Energy/fatigue	1.9 units on a scale Standard Deviation 22.4
Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) Overall health rating	1.3 units on a scale Standard Deviation 15.4

SECONDARY outcome

Timeframe: 6 months

Direct medical costs to be calculated included outpatient visits, hospitalizations, pharmaceuticals, etc. However the data collected in this observational study was not enough to support this calculation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Participants who were working for pay and with available data at both time points.

Indirect costs were estimated by using the number of hours missed from work (absenteeism) multiplied by the average hourly labor cost, including wages and benefits, to calculate average lost productivity costs due to absenteeism during the preceding 7 days.

Hours missed from work were assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) questionnaire, in which respondents answer 6 questions related to work productivity and impairment.

Unit costs were taken from official sources (Statistics Sweden, www.scb.se) and published literature.

Outcome measures

Measure	Paricalcitol Capsules n=11 Participants Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism Absenteeism: Baseline	0 Swedish krona per participant Standard Deviation 0
Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism Absenteeism: 6 months	1,318 Swedish krona per participant Standard Deviation 2,642

SECONDARY outcome

Timeframe: Baseline

Population: Full analysis set

Outcome measures

Measure	Paricalcitol Capsules n=49 Participants Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Number of Participants Using Concomitant Medications at Baseline Agents acting on the renin-angiotensin system	39 participants
Number of Participants Using Concomitant Medications at Baseline All other therapeutic products	11 participants
Number of Participants Using Concomitant Medications at Baseline Angiotensin II antagonists, plain	1 participants
Number of Participants Using Concomitant Medications at Baseline Antianemic preparations	10 participants
Number of Participants Using Concomitant Medications at Baseline Antigout preparations	9 participants
Number of Participants Using Concomitant Medications at Baseline Antihypertensives	5 participants
Number of Participants Using Concomitant Medications at Baseline Antiprotozoals	1 participants
Number of Participants Using Concomitant Medications at Baseline Antithrombotic agents	2 participants
Number of Participants Using Concomitant Medications at Baseline Beta blocking agents	22 participants
Number of Participants Using Concomitant Medications at Baseline Blood substitutes and perfusion solutions	10 participants
Number of Participants Using Concomitant Medications at Baseline Calcium channel blockers	27 participants
Number of Participants Using Concomitant Medications at Baseline Calcium homeostasis	1 participants
Number of Participants Using Concomitant Medications at Baseline Cardiac therapy	1 participants
Number of Participants Using Concomitant Medications at Baseline Diuretics	28 participants
Number of Participants Using Concomitant Medications at Baseline Drugs for obstructive airway diseases	1 participants
Number of Participants Using Concomitant Medications at Baseline Drugs used in diabetes	3 participants
Number of Participants Using Concomitant Medications at Baseline Immunosuppressive agents	1 participants
Number of Participants Using Concomitant Medications at Baseline Lipid modifying agents	28 participants
Number of Participants Using Concomitant Medications at Baseline Mineral supplements	10 participants
Number of Participants Using Concomitant Medications at Baseline Vitamins	2 participants

Adverse Events

Paricalcitol Capsules

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Paricalcitol Capsules n=49 participants at risk Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Cardiac disorders Acute myocardial infarction	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Cardiac disorders Cardiovascular disorder	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Cardiac disorders Cardiac failure congestive	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Cardiac disorders Left ventricular failure	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Gastrointestinal disorders Nausea	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
General disorders Asthenia	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
General disorders Chest pain	4.1% 2/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
General disorders General physical health deterioration	4.1% 2/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
General disorders Pyrexia	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Infections and infestations Appendicitis	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Infections and infestations Diverticulitis	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Infections and infestations Pneumonia	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Infections and infestations Urinary tract infection	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Investigations Weight decreased	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Metabolism and nutrition disorders Decreased appetite	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Metabolism and nutrition disorders Dehydration	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Metabolism and nutrition disorders Hyperglycaemia	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Musculoskeletal and connective tissue disorders Back pain	4.1% 2/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Musculoskeletal and connective tissue disorders Muscular weakness	4.1% 2/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Nervous system disorders Ageusia	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Nervous system disorders Ataxia	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Nervous system disorders Cerebral infarction	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Nervous system disorders Cerebrovascular disorder	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Nervous system disorders Cognitive disorder	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Nervous system disorders Coordination abnormal	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Nervous system disorders Dizziness	4.1% 2/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Nervous system disorders Dysarthria	4.1% 2/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Nervous system disorders Hemiparesis	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Nervous system disorders Memory impairment	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Nervous system disorders VIIth nerve paralysis	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Renal and urinary disorders Anuria	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Renal and urinary disorders Azotaemia	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Renal and urinary disorders Glomerulonephritis rapidly progressive	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Renal and urinary disorders Haematuria	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Renal and urinary disorders Renal failure chronic	4.1% 2/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.1% 2/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Vascular disorders Aortic aneurysm rupture	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Vascular disorders Arteriovenous fistula	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Vascular disorders Hypotension	4.1% 2/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Vascular disorders Poor peripheral circulation	2.0% 1/49 • 6 months Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER