Paricalcitol Effect on Anemia in CKD
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Purpose
Although current activated vitamin D therapies are approved for treating secondary hyperparathyroidism in chronic kidney disease (CKD), a large body of experimental data in animals confirms the effects of vitamin D that extend beyond mineral metabolism. Several studies show that the benefits are greater with the newer vitamin D analog paricalcitol when compared with calcitriol.
A large gap exists in our knowledge between epidemiological studies in humans that demonstrate improved outcomes with vitamin D use and observations in preclinical studies demonstrating the pleiotropic effects of vitamin D. To explore the provenance of epidemiological outcomes in patients with CKD, we conducted a pilot placebo-controlled trial to determine whether the use of paricalcitol leads to improvement in anemia, a marker associated with worse outcomes in chronic kidney disease, and whether this effect not only reflects the hyperparathyroidism correction, but is also dependent on the direct effects of paricalcitol on erythroid progenitor cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia Chronic Kidney Disease |
Drug: Paricalcitol Drug: Calcitriol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Direct Effect of Paricalcitol on Anemia in Chronic Kidney Disease |
- Modification in hemoglobin levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | October 2010 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Control
Patients not treated by vitamin D because not hyperparathyroidic and/or patients already receiving treatment for secondary hyperparathyroidism with calcitriol. The calcitriol dosage schedule provided for an initial dose calculated according to body weight (0.01 mg/kg thrice weekly), and titration was performed on the basis of the serum levels of intact PTH (iPTH) (target 150-300 pg/mL), Ca, P and Ca x P product as suggested by the US National Kidney Foundation Dialysis outcomes Quality Initiative (NKF-DOQI) and Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. At the same way, the patients not treated started therapy if their values needed, as suggested by the NKF-DOQI and KDIGO guidelines
|
Drug: Calcitriol
Rocaltrol cp 0,25 mcg, 0,5 mcg or 1 mcg/die or alternate days per os
Other Name: Rocaltrol
|
|
Experimental: Paricalcitol
Patients treated by Paricalcitol for hyperparathyroidism. The paricalcitol initial dose was 1 mcg/die, and titration was performed on the basis of the serum levels of iPTH, Ca, P and Ca x P product as suggested by the NKF-DOQI and KDIGO guidelines.
|
Drug: Paricalcitol
Zemplar cp 1 mcg or 2 mcg/die per os
Other Name: Zemplar
|
Detailed Description:
To better understand the direct effects of paricalcitol on anemia in patients with chronic kidney disease (stage 3-5), we conducted a pilot trial in 60 patients who were randomly allocated equally to 2 groups to receive or not paricalcitol orally for 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- age > 18
- written informed consent
- CKD stage 3-5 (eGFR <60 ml/min/1,73 m2)
- PTH 20-300 pg/ml
- Hb <10 g/dl >3 consecutive months
- Ferritin > 100 ng/ml
- transferrin saturation (TSAT) 20-40%
- mean corpuscolar volume (MCV) 85-95%
- for patients treated with Ace-inhibitors or angiotensin receptor blockers, dose stable >3 months
- for patients treated with erythropoiesis-stimulating agents (ESA), dose stable >3 months
Exclusion criteria:
- anemia due to non renal cause
- presence of malignancies, inflammatory or infectious disease >3 months
- pregnancy
- bleeding >6 months
- C-reactive protein (CRP) >1 mg/dl
- poorly controlled hypertension (PAS > 170 mmHG and PAD >100 mmHg)
- severe malnutrition
- hypercalcemia (>10,5 mg/dl)
- hyperphosphatemia (>5,5 mg/dl)
- surgical interventions >3 months
- acute myocardial infarction, unstable angina, stroke or transitory ischemic attack, deep venous or pulmonary thromboembolism, congestive heart failure >3 months
Contacts and Locations More Information
No publications provided
| Responsible Party: | Eleonora Riccio, MD, Federico II University |
| ClinicalTrials.gov Identifier: | NCT01768351 History of Changes |
| Other Study ID Numbers: | PCX1234, paranemia |
| Study First Received: | January 13, 2013 |
| Last Updated: | January 13, 2013 |
| Health Authority: | Italy: National Bioethics Committee |
Keywords provided by Federico II University:
|
anemia chronic kidney disease vitamin D paricalcitol hyperparathyroidism |
Additional relevant MeSH terms:
|
Anemia Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Hematologic Diseases Urologic Diseases Renal Insufficiency Calcitriol Ergocalciferols Vitamins Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013