N/A
Completed N=500
Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience
Chronic Kidney Failure · Hyperparathyroidism
Source: ClinicalTrials.gov NCT01083186 ↗
Enrolled (actual)
500
Serious AEs
3.8%
Results posted
Mar 2013
Primary outcomePrimary: Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population — 232.1; 200.1; 166.6; 157.3 pg/mL
Summary
The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and secondary hyperparathyroidism.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population |
232.1; 200.1; 166.6; 157.3; 135.2; 119.4 | — |
| PRIMARY Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants |
321.5; 269.3; 240.1; 271.4; 299.7; 182.9 | — |
| SECONDARY Median Time to Attain the First Lower Intact Parathormone (iPTH) Levels |
7.8 | — |
| SECONDARY Mean Duration of Effect Sustainability (Months) |
3.8 | — |
| SECONDARY Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range |
11; 486; 75; 357; 76; 329 | — |
| SECONDARY Number of Participants With Serum Calcium Level Abnormalities |
384; 77; 409; 62; 391; 45 | — |
| SECONDARY Number of Participants With Serum Phosphorus Level Abnormalities |
367; 84; 361; 105; 326; 103 | — |
| SECONDARY Change in Dipstick Albuminuria Grade From Baseline to Month 6 |
19; 1; 10; 2; 0; 1 | — |
| SECONDARY Change in Dipstick Albuminuria Grade From Baseline to Month 12 |
18; 3; 6; 3; 0; 0 | — |
| SECONDARY Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study |
7.2; 6.9; 7.0; 6.9 | — |
| SECONDARY Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs) |
192; 180; 19 | — |
| SECONDARY Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study |
0; 234; 266; 0; 2; 214 | — |
| SECONDARY Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study |
30.4; 29.9; 29.6; 29.6; 29.6; 29.1 | — |
| SECONDARY Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12 |
20.2; -0.4; 0.3 | — |
| SECONDARY Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12 |
21.1; 0.0; -0.9 | — |
| SECONDARY Change From Baseline in Creatinine Levels at Months 6 and 12 |
2.4; 0.2; 0.4 | — |
| SECONDARY Change From Baseline in Urea Levels at Months 6 and 12 |
99.0; 2.2; 7.2 | — |
| SECONDARY Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12 |
124.0; -5.0; -10.3 | — |
| SECONDARY Change From Enrollment in Total Cholesterol Levels at Months 6 and 12 |
186.3; -3.8; -5.4 | — |
| SECONDARY Change From Enrollment in Triglyceride Levels at Months 6 and 12 |
151.0; -10.2; -10.3 | — |
| SECONDARY Change From Enrollment in Low Density Lipoprotein Cholesterol (LDL-C) Levels at Months 6 and 12 |
106.8; -1.6; 0.1 | — |
| SECONDARY Change From Enrollment in High Density Lipoprotein Cholesterol (HDL-C) Levels at Months 6 and 12 |
49.8; -1.1; -0.7 | — |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12 |
1.9; -0.8; 0.5 | — |
| SECONDARY Homocysteine Values Throughout the Study |
24.8; 24.3; 23.2; 23.4; 24.7; 22.4 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with secondary hyperparathyroidism in the presence of chronic kidney disease stage 3, 4 or 5 treated with Zemplar (paricalcitol) oral for at least 1 month prior to study enrollment
- Male and female (not pregnant or not planning to be pregnant in the next 12 months) patients > 18 years of age
- Signed informed consent by subject
- Hypertensive and diabetic subjects must be on an optimal and steady medication regimen for more than 30 days
Exclusion Criteria
- Contraindications listed in the Summary of Product Characteristics for Zemplar capsules apply (Appendix I and II)
- Parathormone value of > 1000 pg/mL (sign of tertiary hyperparathyroidism)
- Treatment with Vitamin D within the last 1 month prior to inclusion into the study
Data sourced from ClinicalTrials.gov (NCT01083186). 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.