Chronic Kidney Disease Stage V, Hemodialysis
Conditions
Keywords
Venezuelan Patients, Depressive Symptoms, Health Related Quality of Life
Brief summary
This study was designed to evaluate the effectiveness, safety, and impact on quality of life when paricalcitol (Zemplar® intravenous \[IV\]) is administered in Venezuelan patients on hemodialysis who are at risk of developing secondary hyperparathyroidism associated with stage V chronic kidney disease.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 years old with documented diagnosis of stage V chronic kidney disease, on hemodialysis at study baseline * Subjects who have been previously treated with vitamin D or its metabolites or naïve to paricalcitol * Subjects in whom the use of paricalcitol is clinically indicated and documented by applicable and routine standard of healthcare (i.e. laboratory assessments and clinical evaluations) according to the criteria of the attending physician and in accordance with the approved label of the product in Venezuela * Subjects that provide written informed consent form stating his/her authorization and willingness to participate in the study and allowing the use and discussion of his/her personal and/or health information before entering the study * Female subjects with reproductive potential must use an approved contraceptive method (intrauterine device, birth control pills or barrier device) during and for three (03) months after discontinuation of treatment
Exclusion criteria
* Subjects with severe hyperparathyroidism (parathyroid hormone \[PTH\] \> 3000 pg/mL) * Subjects with hypercalcemia, adjusted according to serum albumin, hyperphosphatemia, or subjects with calcium-phosphorus product (Ca x P) ≥ 70 * Known hypersensitivity and/or toxicity of vitamin D, its metabolites and/or other components of Zemplar® IV (paricalcitol) * Subjects who have participated in clinical trials within 30 days before the start of the study or who are currently enrolled in a clinical trial or under treatment with any investigational product * Subjects who cannot tolerate or cannot take phosphate binders that do not contain calcium and/or aluminum * Subjects who in the opinion of the investigator, for any reason (including medical reasons) are not eligible and/or appropriate for therapy with synthetic analogs of vitamin D and/or unwilling to complete the study visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit | Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL | Baseline to Week 12, Week 12 to Week 24 | Participants who achieved PTH Levels \< 300 pg/mL between the first and third study visit (Baseline to Week 12) and the third and final study visit (Week 12 to Week 24). |
| Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks | Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit) | Number of participants achieving PTH level reductions to \< 300 pg/mL or 30% below Baseline in 12 weeks (Baseline to Week 12 or Week 12 to Week 24) or in 24 weeks (Baseline to Week 24). |
| Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 | Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit) | Hypercalcemia was defined as a value of serum calcium (Ca) greater than or equal to 10.3 mg/dL. Hyperphosphatemia was defined as a value of serum phosphorus (P) greater than or equal to 5.5 mg/dL. Elevated Ca×P was defined as as greater or equal to 56.65 mg\^2/dL\^2, calculated as the result of multiplying the maximum values of calcium (10.3 mg/dL) and phosphorus (5.5 mg/dL). |
| European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24 | Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit) | The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a VAS. For the VAS portion, health status is assessed by participants on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'worst imaginable health state' (0) and 'best imaginable health state' (100). |
| Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit | Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit) | BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome. |
| European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit) | The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS). For each parameter other than the VAS, participants are asked to indicate which of 5 statements (from 'no problem' to 'extreme problem') best describes their health state. |
Countries
Venezuela
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paricalcitol IV Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria. | 105 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Premature Study Termination | 44 |
Baseline characteristics
| Characteristic | Paricalcitol IV |
|---|---|
| Age, Continuous | 53.00 years STANDARD_DEVIATION 13.9 |
| Sex/Gender, Customized Female | 37 participants |
| Sex/Gender, Customized Male | 67 participants |
| Sex/Gender, Customized Not Reported | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 105 |
| serious Total, serious adverse events | 9 / 105 |
Outcome results
Primary
Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit
Time frame: Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)
Population: Participants with valid PTH values at Baseline and Final Study Visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paricalcitol IV | Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit | 62 percentage of participants |
Secondary
Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit
BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome.
Time frame: Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit)
Population: Participants with a complete, valid assessment at given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paricalcitol IV | Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit | 10.39 units on a scale | Standard Deviation 7.04 |
| Paricalcitol IV: Week 12 | Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit | 7.96 units on a scale | Standard Deviation 5.75 |
Secondary
European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24
The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS). For each parameter other than the VAS, participants are asked to indicate which of 5 statements (from 'no problem' to 'extreme problem') best describes their health state.
Time frame: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
Population: Participants with valid assessments at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: Severe | 3 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: Severe | 2 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: Unknown | 8 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: Unable to Walk About | 1 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: Moderate | 13 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: No Problems | 53 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: Unknown | 7 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: Slight | 41 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: Slight Problems | 26 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: No Problems | 64 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: None | 39 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: Moderate Problems | 9 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: Moderate Problems | 13 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: Unknown | 8 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: Severe Problems | 5 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: Moderate | 4 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: Unable to Do Usual Activities | 3 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: No Problems | 80 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: Slight Problems | 13 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: Slight | 24 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: Slight Problems | 8 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: Extreme | 0 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: None | 66 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: Moderate Problems | 5 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: Severe Problems | 5 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: Unknown | 7 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: Severe Problems | 0 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: Unknown | 8 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: Extreme | 2 participants |
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: Unable to Wash or Dress Self | 3 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: Moderate | 2 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: No Problems | 36 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: Slight Problems | 15 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: Moderate Problems | 6 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: Severe Problems | 3 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: Unable to Walk About | 0 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: Unknown | 10 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: No Problems | 50 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: Slight Problems | 3 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: Moderate Problems | 3 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: Severe Problems | 3 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: Unable to Wash or Dress Self | 1 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: Unknown | 10 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: No Problems | 37 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: Slight Problems | 13 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: Moderate Problems | 6 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: Severe Problems | 2 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: Unable to Do Usual Activities | 2 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: Unknown | 10 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: None | 30 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: Slight | 20 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: Moderate | 9 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: Severe | 1 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: Extreme | 0 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: Unknown | 10 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: None | 46 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: Slight | 11 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: Severe | 0 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: Extreme | 0 participants |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: Unknown | 11 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: No Problems | 27 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: Moderate | 10 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: Unable to Wash or Dress Self | 0 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: Severe | 0 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: Severe | 1 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: Severe Problems | 0 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: Moderate Problems | 8 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: Extreme | 0 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: Moderate Problems | 3 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: Unknown | 0 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: Unknown | 0 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: Slight Problems | 7 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: Extreme | 0 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: None | 39 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: No Problems | 40 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: Slight Problems | 13 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: Slight | 9 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: Severe Problems | 1 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: Unknown | 0 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: Unable to Do Usual Activities | 1 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: Moderate Problems | 5 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: Unable to Walk About | 0 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: Unknown | 0 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: Slight Problems | 15 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Anxiety/Depression: Moderate | 2 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: None | 21 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Usual Activities: No Problems | 28 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Mobility: Severe Problems | 2 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Pain/Discomfort: Slight | 18 participants |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | Self-Care: Unknown | 0 participants |
Secondary
European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24
The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a VAS. For the VAS portion, health status is assessed by participants on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'worst imaginable health state' (0) and 'best imaginable health state' (100).
Time frame: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
Population: Participants with valid assessments at given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paricalcitol IV | European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24 | 77.98 units on a scale | Standard Deviation 16.21 |
| Paricalcitol IV: Week 12 | European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24 | 84.31 units on a scale | Standard Deviation 14.52 |
| Paricalcitol IV: Week 24 | European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24 | 80.33 units on a scale | Standard Deviation 18.28 |
Secondary
Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL
Participants who achieved PTH Levels \< 300 pg/mL between the first and third study visit (Baseline to Week 12) and the third and final study visit (Week 12 to Week 24).
Time frame: Baseline to Week 12, Week 12 to Week 24
Population: All participants; n=participants with valid PTH values at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paricalcitol IV | Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL | Week 12 to Week 24; n=50 | 14 participants |
| Paricalcitol IV | Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL | Baseline to Week 12; n=70 | 14 participants |
Secondary
Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks
Number of participants achieving PTH level reductions to \< 300 pg/mL or 30% below Baseline in 12 weeks (Baseline to Week 12 or Week 12 to Week 24) or in 24 weeks (Baseline to Week 24).
Time frame: Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)
Population: All participants; n=number of participants with valid PTH values at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paricalcitol IV | Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks | Baseline to Week 12 (12 weeks); n=70 | 14 participants |
| Paricalcitol IV | Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks | Week 12 to Week 24 (12 weeks); n=50 | 13 participants |
| Paricalcitol IV | Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks | Baseline to Week 24 (24 weeks); n=50 | 16 participants |
Secondary
Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24
Hypercalcemia was defined as a value of serum calcium (Ca) greater than or equal to 10.3 mg/dL. Hyperphosphatemia was defined as a value of serum phosphorus (P) greater than or equal to 5.5 mg/dL. Elevated Ca×P was defined as as greater or equal to 56.65 mg\^2/dL\^2, calculated as the result of multiplying the maximum values of calcium (10.3 mg/dL) and phosphorus (5.5 mg/dL).
Time frame: Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)
Population: Participants with valid assessments at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paricalcitol IV | Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 | Hyperphosphatemia | 28.57 percentage of participants |
| Paricalcitol IV | Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 | Hypercalcemia | 1.90 percentage of participants |
| Paricalcitol IV | Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 | Elevations of (Ca x P) | 15.23 percentage of participants |
| Paricalcitol IV: Week 12 | Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 | Hyperphosphatemia | 42.85 percentage of participants |
| Paricalcitol IV: Week 12 | Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 | Hypercalcemia | 1.42 percentage of participants |
| Paricalcitol IV: Week 12 | Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 | Elevations of (Ca x P) | 32.85 percentage of participants |
| Paricalcitol IV: Week 24 | Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 | Hypercalcemia | 14.00 percentage of participants |
| Paricalcitol IV: Week 24 | Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 | Elevations of (Ca x P) | 20.00 percentage of participants |
| Paricalcitol IV: Week 24 | Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 | Hyperphosphatemia | 38.00 percentage of participants |