Working… Menu

A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01506947
Recruitment Status : Completed
First Posted : January 10, 2012
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.

Condition or disease Intervention/treatment Phase
Moderate to Severe Secondary Hyperparathyroidism Stage 5 Chronic Kidney Diseases Drug: Paricalcitol Drug: Darbepoetin alfa Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Non-randomised, Single-arm, Open-Label Pilot Clinical Study Evaluating the Effect of PTH Lowering on Erythropoietin Consumption in Calcitriol-Resistant Patients
Actual Study Start Date : May 10, 2012
Actual Primary Completion Date : April 7, 2016
Actual Study Completion Date : April 7, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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.

Drug: Paricalcitol

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:
  • ABT-358
  • Zemplar

Drug: Darbepoetin alfa
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6 [ Time Frame: Baseline and Month 6 ]
  3. Mean Calcium Level at Baseline and Month 6 [ Time Frame: Baseline and Month 6 ]
  4. Mean Phosphorus Level at Baseline and Month 6 [ Time Frame: Baseline and Month 6 ]
  5. Mean Alkaline Phosphatase Level at Baseline and Month 6 [ Time Frame: Baseline and Month 6 ]
  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

  7. 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

  8. Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6 [ Time Frame: Baseline and Month 6 ]
  9. Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6 [ Time Frame: Baseline and Month 6 ]
  10. 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:

    • An event that resulted in the death of a participant;
    • An event that, in the opinion of the investigator, would have resulted in immediate fatality if medical intervention had not been taken (life-threatening);
    • Resulted in an admission to the hospital for any length of time or prolonged hospital stay;
    • An anomaly detected at or after birth, or any anomaly that results in fetal loss;
    • An event that resulted in a condition that substantially interfered with the activities of daily living;
    • An important medical event that may not be immediately life-threatening or result in death or hospitalization, but based on medical judgment may have jeopardized the participant and may have required medical or surgical intervention to prevent any of the outcomes listed above.

    Adverse events were assessed by the investigator for possible relationship to study drug.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01506947

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Layout table for investigator information
Study Director: Mahmut Gücük, MD AbbVie
Additional Information:
Layout table for additonal information
Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT01506947    
Other Study ID Numbers: W12-645
First Posted: January 10, 2012    Key Record Dates
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017
Last Verified: April 2017
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Chronic kidney disease
Secondary hyperparathyroidism,
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism, Secondary
Urologic Diseases
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Darbepoetin alfa