Renal ImpairmentPhase 1NCT01141179

The Impact of Renal Impairment on the Pharmacokinetic and Pharmacodynamic of LEO 27847

A Phase 1 study testing LEO 27847 in people with Renal Impairment, run by LEO Pharma at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study will investigate the impact of reduced renal function on the pharmacokinetic and pharmacodynamic profile of LEO 27847. Volunteers with different degrees of renal impairment will be administered one dose of the investigational drug and then followed until investigational drug is eliminated from the body. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Renal Impairment
What is being tested?: LEO 27847
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteCanada
Study dates: May 2010to Feb 2011
Phase: Phase 1
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Main Inclusion Criteria:

Male and/or non-childbearing potential female, 18 years of age and older, healthy or with stable renal impairment (deemed stable by the referring physician for at least the last 4 weeks and not expected to change significantly during the next 3 months)
BMI ≥18.0 and ≤ 42 kg/m2
Patients with stable concomitant medical conditions
Healthy subjects or patients with a creatinine clearance (at the time of screening) estimated using the formula of Cockcroft and Gault within the range of:
≥ 50 to ≤ 80 mL/min (Mild Group: 8 subjects),
≥ 30 to < 50 mL/min (Moderate Group: 8 subjects),
< 30 mL/min (Severe Group: 8 subjects).

Main Exclusion Criteria:

Patients with renal transplants or currently on haemodialysis or peritoneal dialysis
Clinically significant illness or surgery within 4 weeks prior to dosing
Clinically significant ECG abnormalities or vital sign abnormalities at screening
History of stroke, cerebrovascular disorder, coronary angioplasty and coronary bypass graft
Clinically significant history or presence of any gastrointestinal pathology
Use of medications other than their stable medications within 14 days prior to administration of investigational product or over-the-counter products within 7 days prior to administration of investigational product, except for:
multivitamins or vitamin D taken on a regular basis
topical products without systemic absorption
Hemoglobin ≤ 90 g/L
Serum total calcium (adjusted for albumin) level < 2.25 mmol/L
Clinically significant history of congestive heart failure, cardiac dysfunction or liver disease

Trial locations and contacts

1 site in 1 country.

Canada1 site

Anapharm
Toronto, Ontario, M2P 1N6

Other trials in Canada

About this study

Conditions: Renal Impairment
Being tested: LEO 27847
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LEO 27847Drug
2 mL (0.1 mg) dose of oral solution

Study groups in NCT01141179
Study group	Role	What they receive
LEO 27847	Experimental	Not described Receives: Drug: LEO 27847

What is being measured

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

PK parameters
(AUC, Cmax)in each group of renal impairment
Measured: 1 week

Secondary outcomes (1)

PD parameters
(Calcium, phosphate, PTH), Vitamin D in each group of renal impairment
Measured: 1 week

Timeline

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

May 2010Feb 2011

First posted10 Jun 2010 (estimated)
Study startMay 2010
Primary completionFeb 2011
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal ImpairmentStudies 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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01141179
Sponsor's protocol ID: LEO 27847-S03
Status last verified: Nov 2013
First submitted: 9 Jun 2010
Last updated: 24 Feb 2025
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Renal Impairment on the Pharmacokinetic and Pharmacodynamic of LEO 27847
ClinicalTrials.gov ID: NCT01141179
Acronym / sponsor ID: LEO 27847-S03
Conditions: Renal Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 10 Jun 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LEO 27847	Experimental	Drug: LEO 27847

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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
LEO 278472 mL (0.1 mg) dose of oral solution	Drug	LEO 27847

Primary outcome

PK parameters
Time frame: 1 week
(AUC, Cmax)in each group of renal impairment

1 secondary outcome

PD parameters
Time frame: 1 week

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
Individual participant dataSharing planned: No

Related trials for Renal Impairment

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

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.

Richard Larouche, MD principal investigator

Anapharm

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LEO 27847 in people with Renal Impairment, run by LEO Pharma at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

PK parameters (time frame: 1 week). 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 NCT01141179.

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 24 Feb 2025.