N/A
Completed N=50
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
Source: ClinicalTrials.gov NCT01265992 ↗Enrolled (actual)
50
Serious AEs
24.5%
Results posted
Feb 2014
Primary outcomePrimary: Change From Baseline in Intact Parathyroid Hormone at 6 Months — -6.2 pmol/L
Summary
Paricalcitol capsules (Zemplar®) received marketing authorization in Sweden in late 2007 for the prevention and treatment of secondary hyperparathyroidism in patients with Stage 3 & 4 Chronic Kidney Disease (CKD). Accordingly, additional data is needed to evaluate the effectiveness and safety of paricalcitol therapy under conditions of usual clinical care in Sweden.
This observational study is designed to collect data to evaluate safety and effectiveness during 6 months of therapy with paricalcitol capsules prescribed for patients with CKD Stages 3-5 not yet on dialysis. Data will also be collected on patient quality of life and costs associated with patient care.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Intact Parathyroid Hormone at 6 Months |
-6.2 | — |
| PRIMARY Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months |
15.0; 27.5 | — |
| PRIMARY Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months |
15.0; 25.0 | — |
| PRIMARY Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months |
42.5; 42.5 | — |
| SECONDARY Change From Baseline in Proteinuria |
0.2 | — |
| SECONDARY Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline |
10.0 | — |
| SECONDARY Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) |
-0.4; -0.2; -1.0; -10.4; -2.5; 1.7 | — |
| SECONDARY Total Direct Costs of Care Associated With Secondary Hyperparathyroidism |
— | — |
| SECONDARY Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism |
0; 1,318 | — |
| SECONDARY Number of Participants Using Concomitant Medications at Baseline |
39; 11; 1; 10; 9; 5 | — |
Eligibility Criteria
Inclusion Criteria
Patients must sign the Informed Consent Form prior to inclusion into the study
- Patients should satisfy the Swedish Summary of Product Characteristics (SPC) for paricalcitol capsules at www.fass.se
- Patients must be 18 years or older with a diagnosis of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 - 5 (estimated Glomerular Filtration Rate between 10-59 by Modification of Diet in Renal Disease) but not yet on dialysis
- Patients should be in stable condition and have a life expectancy of at least 6 months
- Patients should not be expected to be transplanted or initiate dialysis for at least 6 months
Exclusion Criteria
- Patients with CKD receiving dialysis
- Patients contraindicated for paricalcitol capsules as described in the SPC
- Treatment with paricalcitol more than 20 days prior to study enrollment
- History of drug or alcohol abuse within 6 months prior to inclusion
- History of non-compliance with medication or a medical history (i.e. psychiatric) that could enhance non-compliance with medication as determined by the investigator
Data sourced from ClinicalTrials.gov (NCT01265992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.