IgA NephropathyPhase 4NCT00922311
Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade
A Phase 4 study testing Aliskiren in people with IgA Nephropathy, run by The University of Hong Kong at 2 sites in China.
Trial summary
Study objective: To investigate the potential anti-proteinuric efficacy of aliskiren, a novel direct renin inhibitor (DRI), in addition to angiotensin receptor blocker (ARB) in immunoglobulin A nephropathy (IgAN) patients at risk of developing progressive renal failure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Aliskiren
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2009to Dec 2010
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 - 70 years of age
- Histologic diagnosis of IgA nephropathy
- Proteinuria > 1 g/day or UPC > 1 mg/mg or 113 mg/mmol at least twice
- Receiving treatment with the maximum dose of ARB for at least 3 months
- Patients who are willing to give written, informed consent
Who cannot join
- eGFR < 15 ml/min/1.73 sq.m
- UPC >5000 mg/g or 570 mg/mmol, or <500 mg/g or 57 mg/mmol
- Serum K+ > 5.2 mmol/L
- Presence of bilateral renal artery stenosis
- Presence of diabetes mellitus
- Renal histology showing pathologies other than IgAN
Show all 15Show fewer
- Known allergy to ARB or DRI
- Patients on ARB/ACEi combination within 12 weeks of randomization
- Concurrent treatment with corticosteroids, Nsaid, or immunosuppressant
- Patients with connective tissue disease or obstructive uropathy
- Patients with malignancy or conditions severely limiting life expectancy
- Female who are pregnant or intending to conceive
- Female of child-bearing age unwilling to practice contraception
- Patients who are unable to give informed consent
- Patients simultaneously participating in another study
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Medicine, The University of Hong Kong
Hong Kong
Queen Mary Hospital
Hong Kong
About this study
Official title: Aliskiren Combined With Losartan in Immunoglobulin A Nephropathy: an Open-label Pilot Study
Study objective: To investigate the potential anti-proteinuric efficacy of aliskiren, a novel direct renin inhibitor (DRI), in addition to angiotensin receptor blocker (ARB) in immunoglobulin A nephropathy (IgAN) patients at risk of developing progressive renal failure.
Read the detailed description
This will be an open-label pilot study in which IgAN patients with persistent proteinuria despite maximum dose of ARB treatment will be assigned to receive Aliskiren. There is the optional addition of other anti-hypertensive agents to achieve an optimal target blood pressure of <130/80 mmHg.
- Conditions
- IgA Nephropathy
- Being tested
- Aliskiren
- Keywords
- Proteinuria
- Medical subject headings
- Glomerulonephritis, IGA, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
Also called Rasilez
Titrate from 150 mg daily to 300 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren | Experimental | Not described Receives: Drug: Aliskiren |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of urine protein excretion rate
Measured: 6 months
Secondary outcomes (1)
Changes in serum creatinine, eGFR, serum potassium and albumin
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, United Christian Hospital
- Investigators
- Sydney CW Tang, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922311
- Sponsor's protocol ID
- Novartis-ST-01
- Status last verified
- Jul 2015
- First submitted
- 14 Jun 2009
- Last updated
- 3 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tang SC, Lin M, Tam S, Au WS, Ma MK, Yap DY, Ho YW, Lai KN. Aliskiren combined with losartan in immunoglobulin A nephropathy: an open-labeled pilot study. Nephrol Dial Transplant. 2012 Feb;27(2):613-8. doi: 10.1093/ndt/gfr349. Epub 2011 Jun 16.
PubMed 21680850
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aliskiren Combined With Losartan in Immunoglobulin A Nephropathy: an Open-label Pilot Study
- ClinicalTrials.gov ID
- NCT00922311
- Acronym / sponsor ID
- Novartis-ST-01
- Conditions
- IgA Nephropathy
- Keywords
- Proteinuria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, United Christian Hospital
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Jun 2009 (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 objective: To investigate the potential anti-proteinuric efficacy of aliskiren, a novel direct renin inhibitor (DRI), in addition to angiotensin receptor blocker (ARB) in immunoglobulin A nephropathy (IgAN) patients at risk of developing progressive renal failure.
Detailed description
This will be an open-label pilot study in which IgAN patients with persistent proteinuria despite maximum dose of ARB treatment will be assigned to receive Aliskiren. There is the optional addition of other anti-hypertensive agents to achieve an optimal target blood pressure of <130/80 mmHg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aliskiren | Experimental | Drug: Aliskiren |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female 18 - 70 years of age
- Histologic diagnosis of IgA nephropathy
- Proteinuria > 1 g/day or UPC > 1 mg/mg or 113 mg/mmol at least twice
- Receiving treatment with the maximum dose of ARB for at least 3 months
- Patients who are willing to give written, informed consent
Key exclusion criteria (15 listed)
- eGFR < 15 ml/min/1.73 sq.m
- UPC >5000 mg/g or 570 mg/mmol, or <500 mg/g or 57 mg/mmol
- Serum K+ > 5.2 mmol/L
- Presence of bilateral renal artery stenosis
- Presence of diabetes mellitus
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 |
|---|---|---|
| AliskirenAlso: RasilezTitrate from 150 mg daily to 300 mg daily | Drug | Aliskiren |
Primary outcome
Change of urine protein excretion rate
Time frame: 6 months
1 secondary outcome
Changes in serum creatinine, eGFR, serum potassium and albumin
Time frame: 6 months
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 3 Jul 2015.
- Derived from this study: PubMed 21680850Tang SC, Lin M, Tam S, Au WS, Ma MK, Yap DY, Ho YW, Lai KN. Aliskiren combined with losartan in immunoglobulin A nephropathy: an open-labeled pilot study. Nephrol Dial Transplant. 2012 Feb;27(2):613-8. doi: 10.1093/ndt/gfr349. Epub 2011 Jun 16.
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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.
Sydney CW Tang, MD principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aliskiren in people with IgA Nephropathy, run by The University of Hong Kong at 2 sites in China.
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 5 inclusion and 15 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 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Change of urine protein excretion rate (time frame: 6 months). 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 NCT00922311, 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 3 Jul 2015.