Phase 4
N=65
A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
Moderate to Severe Secondary Hyperparathyroidism · Stage 5 Chronic Kidney Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01506947 ↗Enrolled (actual)
65
Serious AEs
16.9%
Results posted
May 2017
Primary outcome: Primary: Mean Erythropoietin Dose Per Visit — 35.8; 22.2; 22.7; 4.7 µg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Paricalcitol (Drug); Darbepoetin alfa (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Erythropoietin Dose Per Visit |
35.8; 22.2; 22.7; 4.7; 7.2; 17.3 | — |
| SECONDARY Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire |
51.7; 51.5; 38.5; 44.3; 52.8; 54.2 | — |
| SECONDARY Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6 |
918.0; 692.5 | — |
| SECONDARY Mean Calcium Level at Baseline and Month 6 |
8.81; 9.29 | — |
| SECONDARY Mean Phosphorus Level at Baseline and Month 6 |
4.87; 5.47 | — |
| SECONDARY Mean Alkaline Phosphatase Level at Baseline and Month 6 |
225.7; 172.9 | — |
| SECONDARY Vitamin B12 Levels |
2; 0; 13; 22; 33; 24 | — |
| SECONDARY Folic Acid Levels |
1; 4; 25; 25; 22; 17 | — |
| SECONDARY Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6 |
11.8; 14.4 | — |
| SECONDARY Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6 |
6267; 11340 | — |
| SECONDARY Number of Participants With Adverse Events |
9; 11; 0; 3 | — |
Summary
To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.
Eligibility Criteria
Inclusion Criteria: A subject will only be included if all the following entry criteria are met:
- Patients ≥ 18 years of age
- Stage 5 chronic kidney disease (CKD) patients receiving hemodialysis and with moderate to severe secondary hyperparathyroidism (SHPT)
- Patients with anemia due to renal insufficiency but who are iron replete:; Transferrin saturation (TSAT) > 20% and Ferritin levels > 200 ng/mL and requiring treatment with erythropoietin (EPO)
- Patients with vitamin B levels > lower limit of normal (LLN) and folic acid levels > LLN
- Patients treated only with intravenous calcitriol for at least 6 months
- Patients with serum intact parathyroid hormone (iPTH) level > 500 pg/mL
- Patients with calcium phosphate product (Ca × PO4) 100 fL) anemia at screening that may be caused by diseases such as for microcytic anemias - Iron Deficiency, Thalassemias, Anemia of Chronic Disease, Copper Deficiency, Zinc poisoning, Sideroblastic Anemia, macrocytic anemias -ethanol abuse, myelodysplastic syndromes, acute myeloid leukemias, reticulocytosis, drug induced anemia, liver disease.
Data sourced from ClinicalTrials.gov (NCT01506947). 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.