- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01506947
A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
A Prospective, Non-randomised, Single-arm, Open-Label Pilot Clinical Study Evaluating the Effect of PTH Lowering on Erythropoietin Consumption in Calcitriol-Resistant Patients
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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) < 65 mg²/dL²
- Patients willing to sign "written informed consents" before participating in any the study related activity.
- Patients with phosphorus levels < 6.5 mg/dL and calcium levels < 11.2 mg/dL
Exclusion Criteria:
A subject will be excluded from the study if he/she meets any of the following criteria:
- Patients who have known hypersensitivity and/or toxicity to vitamin D metabolites and/or to paricalcitol and/or to other product ingredients.
- Patients who have participated in a clinical study within the last month.
- Patients whose previous concomitant medication and laboratory data for 6 months prior to the baseline visit are not available.
- Patients with known contraindication to selective Vitamin D receptor activators (VDRAs) according to the Summary of Product Characteristics (SmPC).
- Pregnancy, breast-feeding or planning a pregnancy within next 6 months after enrollment. Sexually active female patients not accepting appropriate contraceptive methods during the course of the study will also be excluded.
- Hypertensive and diabetic patients who are not on an optimal and steady medication regimen for more than 30 days.
- Patients with microcytic (mean corpuscular volume [MCV] < 80 fL) and macrocytic (MCV > 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Paricalcitol
Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL. Participants may have also received routine darbepoetin alfa to treat anemia. |
Paricalcitol was administered by intravenous bolus. The initial dose was calculated according to the following formula: [Paricalcitol (µg) = iPTH (pg/mL) / 80]. Subsequent doses were determined based on iPTH, calcium and phosphorus levels.
Other Names:
Routine darbepoetin alfa use was allowed when transferrin saturation (TSAT) was ≥ 20% and ferritin ≥ 200 μg/L, and hemoglobin level < 11.5 g/dL.
The initial dose was 0.25 to 0.75 µg/kg/week, and the maintenance dose was 0.13 to 0.35 µg/kg/week.
Target hemoglobin level was between 10 to 11.5 g/dL.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Erythropoietin Dose Per Visit
Time Frame: Baseline and Months 1, 2, 3, 4, 5 and 6
|
The requirement of erythropoietin (EPO) treatment to maintain serum hemoglobin levels between 10 to 11.5 g/dL during the study was assessed by analysis of the dose of darbepoetin alfa used at baseline and during each month of the study.
The mean EPO dosage per injection for each study month is reported.
|
Baseline and Months 1, 2, 3, 4, 5 and 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire
Time Frame: Baseline and Month 6
|
The Medical Outcome Study Short Form 36-Item Health Survey (SF-36) is a self-administered questionnaire that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains.
The domains include physical (physical functioning, role limitations due to physical health (role-physical), general health perceptions and pain) and mental domains (energy/fatigue (vitality), social functioning, emotional well-being (mental health), and role limitations due to emotional problems (role emotional)).
The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.
|
Baseline and Month 6
|
Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6
Time Frame: Baseline and Month 6
|
Baseline and Month 6
|
|
Mean Calcium Level at Baseline and Month 6
Time Frame: Baseline and Month 6
|
Baseline and Month 6
|
|
Mean Phosphorus Level at Baseline and Month 6
Time Frame: Baseline and Month 6
|
Baseline and Month 6
|
|
Mean Alkaline Phosphatase Level at Baseline and Month 6
Time Frame: Baseline and Month 6
|
Baseline and Month 6
|
|
Vitamin B12 Levels
Time Frame: Baseline and month 6
|
Vitamin B12 levels were categorized according to the following laboratory reference ranges: Low: < 200 pg/mL Normal: 200 - 950 pg/mL High: > 950 pg/mL |
Baseline and month 6
|
Folic Acid Levels
Time Frame: Baseline and month 6
|
Folic acid levels were categorized according to the following laboratory reference ranges: Low: < 4.6 ng/mL Normal: 4.6 - 18.7 ng/mL High: > 18.7 ng/mL |
Baseline and month 6
|
Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6
Time Frame: Baseline and Month 6
|
Baseline and Month 6
|
|
Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6
Time Frame: Baseline and Month 6
|
Baseline and Month 6
|
|
Number of Participants With Adverse Events
Time Frame: From the time of study drug administration until 4 weeks after the discontinuation of the study drug; up to 7 months.
|
Serious adverse events were any adverse events meeting any of the following criteria:
Adverse events were assessed by the investigator for possible relationship to study drug. |
From the time of study drug administration until 4 weeks after the discontinuation of the study drug; up to 7 months.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- W12-645
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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