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Stage 5 Chronic Kidney Disease (CKD)Phase 22007NCT01453634

Four Week, Pharmacodynamic/Pharmacokinetic, Efficacy, and Safety Study of Lunacalcipol (CTA018)

A Phase 2 study testing Lunacalcipol 180 and Lunicalcipol 270 in people with Stage 5 Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT), run by OPKO Health, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Open-label, pharmacodynamic, safety, pharmacokinetic and efficacy study of Lunacalcipol Injection. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Lunacalcipol 180 and Lunicalcipol 270
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2013to Jul 2013
Phase
Phase 2
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must have a body mass index (BMI) between 18 and 35 kg/m2, inclusive.
  • Prior to study entry, subjects must be undergoing maintenance HD tiw, be in stable condition (ie, on maintenance HD for at least 8 weeks) and be expected to remain on HD for the duration of the study.
  • Subject must be willing and able to discontinue vitamin D and/or bone metabolism therapy for a minimum 2 week wash-out prior to administration of study drug and through the EOS visit. This includes vitamin D supplements daily dose containing more than 1000 IU of ergocalciferol or cholecalciferol) and analogs (calcitriol, paricalcitol, doxercalciferol), cinacalcet, teriparatide, calcitonin, maintenance glucocorticoids (greater than a prednisone equivalent of 5 mg/day), selective estrogen receptor modulators (SERMs; raloxifene or tamoxifen) or other drugs that may affect Ca metabolism.
  • Subjects must not have taken bisphosphonates for at least 3 months (90 days) prior to the first dose of study drug.
  • Subject laboratory values must be within the following ranges:
  • Plasma iPTH ≥350 pg/mL (35 pmol/L) and <1000 pg/mL (100 pmol/L)
Show all 11Show fewer
  • Total serum Ca ≥8.4 mg/dL (2.1 mmol/L) and <10.0 mg/dL (2.5 mmol/L)
  • Serum P ≥2.5 mg/dL (0.8 mmol/L) and <6.2 mg/dL (2.0 mmol/L)
  • Total serum 25-hydroxyvitamin D level at screening must be ≥15 ng/mL (37 nmol/L).
  • Subject must be willing and able to comply with study instructions and commit to all clinic visits for the duration of the study.
  • Female subjects of childbearing potential must be neither pregnant nor lactating and must have a negative serum pregnancy test at screening and agree to use effective contraception (implants, injectables, combined oral contraceptives, intrauterine device (IUD), sexual abstinence, or vasectomized partner) for the duration of the study.

Who cannot join

  • Subject cannot have clinically significant liver disease (alanine aminotransferase [ALT], aspartate amino transferase [AST] or bilirubin > 2x ULN), or any clinical evidence of significant hepatic dysfunction during the screening period deemed clinically significant by the investigator.
  • Subject cannot be currently taking cytochrome P450 3A inhibitors (eg, ketoconazole or erythromycin) or P450 3A inducers.
  • Subject cannot have a known history of kidney stones within the previous 2 years.
  • Subject cannot have a known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus (HIV) or hepatitis that in the opinion of the investigator may worsen and/or interfere with participation in the study.
  • Subject cannot have a history of neurological/psychiatric disorders, including psychotic disorders or dementia, or any other reason, which in the opinion of the investigator makes adherence to a regular treatment or follow-up schedule unlikely.
  • Subject cannot have any clinically significant abnormalities, as determined by the investigator, based on a 12-lead ECG, PE and laboratory assessments conducted during screening.
  • Subject cannot have a known or suspected hypersensitivity to any of the constituents of the investigational product.
  • Subject cannot be currently participating in or have participated in an interventional/investigational study within 30 days prior to the study.

About this study

Official title: A Randomized, Open Label, Four Week, Pharmacodynamic/Pharmacokinetic, Efficacy, and Safety Study of Lunacalcipol (CTA018) Injection in Subjects With Stage 5 Chronic Kidney Disease With Secondary Hyperparathyroidism on Hemodialysis

Open-label, pharmacodynamic, safety, pharmacokinetic and efficacy study of Lunacalcipol Injection.

Read the detailed description

This is a prospective, open-label, PD, safety, PK and efficacy study of Lunacalcipol Injection. Approximately 12 subjects will be randomized into 1 of 2 treatment groups receiving either 180 µg (n=4) or 270 µg (n=8) Lunacalcipol Injection in a 1:2 ratio, respectively. All subjects are planned to receive a total of 11 doses of the study drug given three times per week (tiw) over 24 days (day 1 to day 24), administered not more often than every other day.

Previously defined criteria relating to serum levels of iPTH, Ca, and P will be reviewed by the Medical Monitor to determine subject safety. If any of the criteria are observed, subjects will be discontinued from the study, receiving no further administration of the study drug and will be followed for safety. Safety data will be reviewed by the Medical Monitor for the first 2 subjects in the 270 µg group. If the first 2 subjects meet dose group discontinuation criteria, including treatment emergent calciphylaxis, treatment-emergent adverse events (TEAEs) related to elevated serum Ca levels, or a reported death associated with elevated serum Ca levels or related to study drug, subjects beyond the first 2 will not be dosed.

A Data and Safety Monitoring Board (DSMB) will be appointed to provide an independent evaluation of all safety data, including all laboratory results and serious adverse events (SAEs). The DSMB will conduct its review after 4 subjects in the 270 µg dose group have completed at least 6 doses, at any time death is reported, or at the request of the DSMB. The DSMB will also conduct an additional review at the End of Study.

Being tested
Lunacalcipol 180, Lunicalcipol 270
Keywords
chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT), hemodialysis (HD)
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.

  • Lunacalcipol 180Drug

    4 subjects are planned to receive a total of 11 doses of the study drug given three times per week (tiw) over 24 days (day 1 to day 24), administered not more often than every other day.

  • Lunicalcipol 270Drug

    8 subjects are planned to receive a total of 11 doses of the study drug given three times per week (tiw) over 24 days (day 1 to day 24), administered not more often than every other day.

Study groups in NCT01453634
Study groupRoleWhat they receive
Lunacalcipol 180Experimental180 µg (n=4)Lunacalcipol Injection
Receives: Drug: Lunacalcipol 180
Lunacalcipol 270Experimental270 µg (n=8)Lunacalcipol Injection
Receives: Drug: Lunicalcipol 270

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure the intact parathyroid hormone (iPTH) levels following Lunacalcipol Injection

    Measured: 3 screening visits will occur within up to 42 days, Subjects will receive a total of 11 doses of study drug given 3 times weekly over 24 days. Following 24 days of treatment, subjects will undergo 2 days of follow-up and an end of study (EOS) assessment.

Secondary outcomes (1)

  1. Assess the safety of Lunacalcipol Injection

    Criteria relating to serum levels of iPTH, Ca, and P will be reviewed by the Medical Monitor. If any of the criteria are observed, subjects will be discontinued from the study and will be followed for safety. Safety data will be reviewed by the Medical Monitor for the first 2 subjects in the 270 µg group. If the first 2 subjects meet dose group discontinuation criteria, subjects beyond the first 2 will not be dosed.

    Measured: 3 screening visits will occur within up to 42 days, Subjects will receive a total of 11 doses of study drug given 3 times weekly over 24 days. Following 24 days of treatment, subjects will undergo 2 days of follow-up and an end of study (EOS) assessment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2011 (estimated)
  2. Study startJan 2013
  3. Primary completionJul 2013 (estimated)
  4. Study completionJul 2013 (estimated)

Why it stopped: The company is no longer pursuing this study.

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01453634
Sponsor's protocol ID
CTA018-2007
Acronym
2007
Status last verified
Sep 2014
First submitted
13 Oct 2011
Last updated
22 Sep 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lunacalcipol 180 and Lunicalcipol 270 in people with Stage 5 Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT), run by OPKO Health, Inc..

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 11 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: withdrawn, as of the sponsor's last update on 22 Sep 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Measure the intact parathyroid hormone (iPTH) levels following Lunacalcipol Injection (time frame: 3 screening visits will occur within up to 42 days, Subjects will receive a total of 11 doses of study drug given 3 times weekly over 24 days. Following 24 days of treatment, subjects will undergo 2 days of follow-up and an end of study (EOS) assessment.). 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 NCT01453634.

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 22 Sep 2014.

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