Moderate to Severe Secondary HyperparathyroidismPhase 4NCT01506947
A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
A Phase 4 study testing Paricalcitol and Darbepoetin alfa in people with Moderate to Severe Secondary Hyperparathyroidism and Stage 5 Chronic Kidney Diseases, run by AbbVie (prior sponsor, Abbott).
Trial summary
To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Secondary Hyperparathyroidism, Stage 5 Chronic Kidney Diseases
- What is being tested?
- Paricalcitol and Darbepoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2012to 7 Apr 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
About this study
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
To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.
- Being tested
- Paricalcitol, Darbepoetin alfa
- Keywords
- Hemodialysis, Chronic kidney disease, Secondary hyperparathyroidism,
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParicalcitolDrug
Also called ABT-358, Zemplar
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.
Darbepoetin alfaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Paricalcitol | Experimental | 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. Receives: Drug: Paricalcitol; Drug: Darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Erythropoietin Dose Per Visit
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.
Measured: Baseline and Months 1, 2, 3, 4, 5 and 6
Secondary outcomes (10)
Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire
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.
Measured: Baseline and Month 6
Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6
Measured: Baseline and Month 6
Mean Calcium Level at Baseline and Month 6
Measured: Baseline and Month 6
Mean Phosphorus Level at Baseline and Month 6
Measured: Baseline and Month 6
Mean Alkaline Phosphatase Level at Baseline and Month 6
Measured: Baseline and Month 6
Vitamin B12 Levels
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
Measured: Baseline and month 6
Folic Acid Levels
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
Measured: Baseline and month 6
Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6
Measured: Baseline and Month 6
Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6
Measured: Baseline and Month 6
Number of Participants With Adverse Events
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.
Measured: From the time of study drug administration until 4 weeks after the discontinuation of the study drug; up to 7 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study start10 May 2012
- Primary completion7 Apr 2016
- Study completion7 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe Secondary HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahmut Gücük, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506947
- Sponsor's protocol ID
- W12-645
- Status last verified
- Jul 2021
- First submitted
- 28 Dec 2011
- Last updated
- 30 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Poordad F, Landis CS, Asatryan A, Jackson DF 3rd, Ng TI, Fu B, Lin CW, Yao B, Kort J. High antiviral activity of NS5A inhibitor ABT-530 with paritaprevir/ritonavir and ribavirin against hepatitis C virus genotype 3 infection. Liver Int. 2016 Aug;36(8):1125-32. doi: 10.1111/liv.13067. Epub 2016 Feb 3.
PubMed 26778412
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01506947
- Acronym / sponsor ID
- W12-645
- Keywords
- Hemodialysis, Chronic kidney disease, Secondary hyperparathyroidism,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- 10 May 2012 (actual)
- Primary completion
- 7 Apr 2016 (actual)
- Study completion
- 7 Apr 2016 (actual)
- First posted
- 10 Jan 2012 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paricalcitol | Experimental | Drug: Paricalcitol, Drug: Darbepoetin alfaParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParicalcitolAlso: ABT-358, ZemplarParicalcitol 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. | Drug | Paricalcitol |
| Darbepoetin alfaRoutine 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. | Drug | Paricalcitol |
Primary outcome
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.
10 secondary outcomes
Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire
Time frame: Baseline and Month 6
Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6
Time frame: Baseline and Month 6
Mean Calcium Level at Baseline and Month 6
Time frame: Baseline and Month 6
Mean Phosphorus Level at Baseline and Month 6
Time frame: Baseline and Month 6
Mean Alkaline Phosphatase Level at Baseline and Month 6
Time frame: Baseline and Month 6
Vitamin B12 Levels
Time frame: Baseline and month 6
Folic Acid Levels
Time frame: Baseline and month 6
Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6
Time frame: Baseline and Month 6
Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26778412Poordad F, Landis CS, Asatryan A, Jackson DF 3rd, Ng TI, Fu B, Lin CW, Yao B, Kort J. High antiviral activity of NS5A inhibitor ABT-530 with paritaprevir/ritonavir and ribavirin against hepatitis C virus genotype 3 infection. Liver Int. 2016 Aug;36(8):1125-32. doi: 10.1111/liv.13067. Epub 2016 Feb 3.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmut Gücük, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paricalcitol and Darbepoetin alfa in people with Moderate to Severe Secondary Hyperparathyroidism and Stage 5 Chronic Kidney Diseases, run by AbbVie (prior sponsor, Abbott).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Erythropoietin Dose Per Visit (time frame: Baseline and Months 1, 2, 3, 4, 5 and 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01506947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.