Focal Segmental GlomerulosclerosisPhase 4TRANSLATENCT02585804

Treating to Reduce Albuminuria and Normalize Hemodynamic Function in Focal ScLerosis With dApagliflozin Trial Effects

A Phase 4 study testing Dapagliflozin in people with Focal Segmental Glomerulosclerosis, run by University Health Network, Toronto at 1 site in Canada.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Focal Segmental Glomerulosclerosis
What is being tested?: Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteCanada
Study dates: Sep 2015to 24 Apr 2017
Phase: Phase 4
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects diagnosed with FSGS ≥1 month prior to informed consent
eGFR≥45 ml/min/1.73m2
Age 18 years or greater
No history of diabetes
Body Mass Index (BMI) 18.5 - 45.0 kg/ m2
Blood pressure ≥ 100/60 at screening
Stable therapy with either an ACEi or angiotensin II receptor blocker or direct renin inhibitor for > 1 month
>30 mg/day and <6 g/day of proteinuria unless the patient is not a candidate for immunosuppressive therapy

Who cannot join

Leukocyte and/or nitrite positive urinalysis that is untreated;
History of organ transplantation, cancer, liver disease;
Bariatric surgery or other gastrointestinal surgeries that induce chronic malabsorption within the past two years;
Current treatment with systemic corticosteroids, calcineurin inhibitors, or other immunosuppressant medications;
Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells;
Pre-menopausal women who are nursing, pregnant, or of child-bearing potential and not practising an acceptable method of birth control;

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Participation in another therapeutic trial with an investigational drug within 30 days prior to informed consent;
Alcohol or drug abuse within three months prior to informed consent that would interfere with trial participation or any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement;
Liver disease, defined by serum levels of alanine transaminase, aspartate transaminase, or alkaline phosphatase >3 x upper limit of normal as determined during screening;
Cardiac, lung or peripheral vascular disease or stroke;
Pancreas, pancreatic islet cells or renal transplant recipient;
Medical history of cancer or treatment for cancer in the last five years prior to screening;
History of allergy or angioedema with RAAS inhibitor exposure;
Kidney disease due primarily to another condition aside from FSGS;

Trial locations and contacts

1 site in 1 country.

Canada1 site

Renal Physiology Laboratory, University Health Network
Toronto, Ontario, M5G 2N2

Other trials in Canada

About this study

Official title: Treating to Reduce Albuminuria and Normalize Hemodynamic Function in Focal ScLerosis With dApagliflozin Trial Effects: "The TRANSLATE Study"

Patients with Focal Segmental Glomerulosclerosis (FSGS) constitute an increasing proportion of the total glomerulonephritis (GN) patient cohort in North America while FSGS is a risk factor for end stage renal failure. Current non-immunological FSGS therapies include the use of angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB), to reduce intraglomerular hypertension. Unfortunately, these agents lead to incomplete renal protection. The aim of the current study is to determine whether the addition of novel sodium glucose cotransport-2 inhibitors (SGLT2i) to standard of care leads to reduced intraglomerular pressure and suppression of proteinuria. We hypothesize that combination therapy of SGLT2i drugs and conventional RAASi results in additive renal protective effects in FSGS patients. A further goal is to examine mechanisms of SGLT2 inhibition by measuring renal hemodynamic function and sodium handling. Kidney function will be assessed in FSGS patients before and after an 8 week treatment with SGLT2i dapagliflozin.

Read the detailed description

FSGS and diabetic nephropathy may have common pathogenic mechanisms, that are mediated by intraglomerular hypertension, leading to hyperfiltration and proteinuria. Given that SGLT2i corrects early hemodynamic abnormalities in patients with diabetes, our aim is to determine if a similar benefit may extend to patients with FSGS. Based on previous experimental and clinical data, we hypothesize that SGLT2i will improve renal hemodynamic abnormalities characteristic of FSGS that promote renal injury and proteinuria.

Conditions: Focal Segmental Glomerulosclerosis
Being tested: Dapagliflozin
Keywords: FSGS, SGLT2, chronic kidney disease, GFR, proteinuria
Medical subject headings: Glomerulosclerosis, Focal Segmental, Renal Insufficiency, Chronic, Proteinuria

What participants receive

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

DapagliflozinDrug
Also called Trade name Farxiga®
Oral tablet, 10mg, PO, 8 weeks

Study groups in NCT02585804
Study group	Role	What they receive
Dapagliflozin (trade name Farxiga®)	Experimental	Oral tablet, 10mg, PO, 8 weeks Receives: Drug: Dapagliflozin

What is being measured

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

The change in Glomerular Filtration Rate (GFR) After an 8 week treatment with dapagliflozin
Glomerular Filtration Rate (GFR, based on plasma inulin clearance) will be measured at baseline and after 8 weeks of treatment.
Measured: Before and after an 8 week treatment with dapagliflozin

Secondary outcomes (4)

The change in Effective Renal Plasma Flow (ERPF) After an 8 week treatment with dapagliflozin
Effective Renal Plasma Flow (ERPF, based on paraaminohippurate plasma clearance) will be measured at baseline and after 8 weeks of treatment.
Measured: Before and after an 8 week treatment with dapagliflozin
The change in Blood Pressure After an 8 week treatment with dapagliflozin
Measured: Before and after 8 weeks of treatment with dapagliflozin
The change in albuminuria after 8 weeks of treatment with dapagliflozin
Measured: Before and after 8 weeks of treatment with dapagliflozin
The change in urinary vasoactive mediators after 8 weeks of treatment with dapagliflozin
Measured: Before and after 8 weeks of treatment with dapagliflozin

Timeline

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

Sep 201524 Apr 2017

First posted23 Oct 2015 (estimated)
Study startSep 2015
Primary completion24 Apr 2017
Study completion24 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Focal Segmental GlomerulosclerosisStudies of the same condition, open and under way.
More trials run by University Health Network, TorontoThe sponsor's other registered studies.
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: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02585804
Sponsor's protocol ID: REB# 14-8284-B
Acronym: TRANSLATE
Status last verified: Jan 2018
First submitted: 22 Oct 2015
Last updated: 16 Jan 2018
Results posted: No
Data monitoring committee: 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

RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
RecruitingPhase 3
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomerulosclerosis
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
Not yet recruitingPhase 2
A Study to Evaluate the Effectiveness and Safety of Sibeprenlimab in Participants With Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, and Minimal Change Disease
Primary Membranous Nephropathy, Minimal Change Disease

All Focal Segmental Glomerulosclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treating to Reduce Albuminuria and Normalize Hemodynamic Function in Focal ScLerosis With dApagliflozin Trial Effects: "The TRANSLATE Study"
ClinicalTrials.gov ID: NCT02585804
Acronym / sponsor ID: TRANSLATE / REB# 14-8284-B
Conditions: Focal Segmental Glomerulosclerosis
Keywords: FSGS, SGLT2, chronic kidney disease, GFR, proteinuria
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University Health Network, TorontoUniversity, hospital or other
Collaborators: AstraZeneca, University of Toronto, Toronto General Hospital
Study start: Sep 2015
Primary completion: 24 Apr 2017 (actual)
Study completion: 24 Apr 2017 (actual)
First posted: 23 Oct 2015 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dapagliflozin (trade name Farxiga®)	Experimental	Drug: DapagliflozinOral tablet, 10mg, PO, 8 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male or female subjects diagnosed with FSGS ≥1 month prior to informed consent
eGFR≥45 ml/min/1.73m2
Age 18 years or greater
No history of diabetes
Body Mass Index (BMI) 18.5 - 45.0 kg/ m2

Key exclusion criteria (14 listed)

Leukocyte and/or nitrite positive urinalysis that is untreated;
History of organ transplantation, cancer, liver disease;
Bariatric surgery or other gastrointestinal surgeries that induce chronic malabsorption within the past two years;
Current treatment with systemic corticosteroids, calcineurin inhibitors, or other immunosuppressant medications;
Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells;

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
DapagliflozinAlso: Trade name Farxiga®Oral tablet, 10mg, PO, 8 weeks	Drug	Dapagliflozin (trade name Farxiga®)

Primary outcome

The change in Glomerular Filtration Rate (GFR) After an 8 week treatment with dapagliflozin
Time frame: Before and after an 8 week treatment with dapagliflozin
Glomerular Filtration Rate (GFR, based on plasma inulin clearance) will be measured at baseline and after 8 weeks of treatment.

4 secondary outcomes

The change in Effective Renal Plasma Flow (ERPF) After an 8 week treatment with dapagliflozin
Time frame: Before and after an 8 week treatment with dapagliflozin
The change in Blood Pressure After an 8 week treatment with dapagliflozin
Time frame: Before and after 8 weeks of treatment with dapagliflozin
The change in albuminuria after 8 weeks of treatment with dapagliflozin
Time frame: Before and after 8 weeks of treatment with dapagliflozin
The change in urinary vasoactive mediators after 8 weeks of treatment with dapagliflozin
Time frame: Before and after 8 weeks of treatment with dapagliflozin

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 16 Jan 2018.

Related trials for Focal Segmental Glomerulosclerosis

RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
RecruitingPhase 3
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomerulosclerosis
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
Not yet recruitingPhase 2
A Study to Evaluate the Effectiveness and Safety of Sibeprenlimab in Participants With Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, and Minimal Change Disease
Primary Membranous Nephropathy, Minimal Change Disease

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozin in people with Focal Segmental Glomerulosclerosis, run by University Health Network, Toronto 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?

The sponsor lists 8 inclusion and 14 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 16 Jan 2018. 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 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?

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?

The change in Glomerular Filtration Rate (GFR) After an 8 week treatment with dapagliflozin (time frame: Before and after an 8 week treatment with dapagliflozin). 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 NCT02585804.

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 16 Jan 2018.