IgA NephropathyPhase 2NCT01224028
A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients
A Phase 2 study testing Tacrolimus in people with IgA Nephropathy, run by Astellas Pharma Inc at 1 site in South Korea.
Trial summary
This study is to evaluate efficacy and safety of tacrolimus in the patients with non-nephrotic albuminuric, normotensive IgA nephropathy after 16 week treatment with tacrolimus (Prograf) or placebo. 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?
- Tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2010to Jun 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with IgA nephropathy confirmed by renal biopsy
- Serum creatinine measurement ≤1.5mg/ml or MDRD estimated GFR ≥ 45ml/min/1.73m2 (MDRD: Modification of Diet in Renal Disorder)
- UACR level between 0.3 and 3.0
- Blood pressure measurements < 130/80mmHg
Who cannot join
- Use of immunosuppressants for more than two weeks within last one month
- Concomitant use of ACE inhibitor, ARB, steroids or immunosuppressant, NDHP-CCB, diuretics, omega-3 fatty acids and its analogue \& additional dietary to treat igA nephropathy (ACE: Angiotensin Converting Enzyme, ARB: Angiotensin Receptor Blocker, NDHP-CCB: Non-dihydropyridine-type Calcium Channel Blocker
- Pregnant or breast-feeding patients. Patients who plan to bear children or breast-feed during the study and within 6 month after completion of study
- Hypersensitivity to the investigational drug or macrolide agents
- Use of potassium-sparing diuretics
- Persistence of liver function abnormality more than 1 month or presence of acute active hepatitis
- Other investigational drug within last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized Placebo-controlled Clinical Trial for the Efficacy and Safety of a Calcineurin Inhibitor, Tacrolimus(Prograf Cap®) in Patients With Non-nephrotic Albuminuric, Normotensive IgA Nephropathy
This study is to evaluate efficacy and safety of tacrolimus in the patients with non-nephrotic albuminuric, normotensive IgA nephropathy after 16 week treatment with tacrolimus (Prograf) or placebo.
- Conditions
- IgA Nephropathy
- Being tested
- Tacrolimus, Placebo
- Keywords
- Tacrolimus, Prograf, Calcinurin inhibitor, Albuminurea, Proteinurea, FK506
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograf, FK506
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus group | Experimental | Not described Receives: Drug: Tacrolimus |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio)
Measured: Week 0, week 12 and week 16
Secondary outcomes (6)
Proportion of subjects achieving more than 30% reduction of UACR level from baseline
Measured: Week 0 and week 16
Proportion of subjects achieving more than 50% reduction of UACR level from baseline
Measured: Week 0 and week 16
Proportion of subjects achieving more than 0.2 reduction of UACR level
Measured: Week 0 and week 16
Composite event rate achieving less than 0.2 or 50% reduction of UACR level
Measured: Week 0 and week 16
Changes of UACR measured between before the study and each visit
Measured: Week 0, week 4, week 8, week 12 and week 16
Incidence of adverse events according to subject's self-assessment, vital signs, investigator's assessment and labo-tests
Measured: Through week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionJun 2011
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Korea, Inc.
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224028
- Sponsor's protocol ID
- PRGNS-10-01-KOR
- Status last verified
- Aug 2014
- First submitted
- 18 Oct 2010
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim YC, Chin HJ, Koo HS, Kim S. Tacrolimus decreases albuminuria in patients with IgA nephropathy and normal blood pressure: a double-blind randomized controlled trial of efficacy of tacrolimus on IgA nephropathy. PLoS One. 2013 Aug 19;8(8):e71545. doi: 10.1371/journal.pone.0071545. eCollection 2013.
PubMed 23977072
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized Placebo-controlled Clinical Trial for the Efficacy and Safety of a Calcineurin Inhibitor, Tacrolimus(Prograf Cap®) in Patients With Non-nephrotic Albuminuric, Normotensive IgA Nephropathy
- ClinicalTrials.gov ID
- NCT01224028
- Acronym / sponsor ID
- PRGNS-10-01-KOR
- Conditions
- IgA Nephropathy
- Keywords
- Tacrolimus, Prograf, Calcinurin inhibitor, Albuminurea, Proteinurea, FK506
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Korea, Inc.
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 Oct 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.
This study is to evaluate efficacy and safety of tacrolimus in the patients with non-nephrotic albuminuric, normotensive IgA nephropathy after 16 week treatment with tacrolimus (Prograf) or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus group | Experimental | Drug: Tacrolimus |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with IgA nephropathy confirmed by renal biopsy
- Serum creatinine measurement ≤1.5mg/ml or MDRD estimated GFR ≥ 45ml/min/1.73m2 (MDRD: Modification of Diet in Renal Disorder)
- UACR level between 0.3 and 3.0
- Blood pressure measurements < 130/80mmHg
Key exclusion criteria (7 listed)
- Use of immunosuppressants for more than two weeks within last one month
- Concomitant use of ACE inhibitor, ARB, steroids or immunosuppressant, NDHP-CCB, diuretics, omega-3 fatty acids and its analogue \& additional dietary to treat igA nephropathy (ACE: Angiotensin Converting Enzyme, ARB: Angiotensin Receptor Blocker, NDHP-CCB: Non-dihydropyridine-type Calcium Channel Blocker
- Pregnant or breast-feeding patients. Patients who plan to bear children or breast-feed during the study and within 6 month after completion of study
- Hypersensitivity to the investigational drug or macrolide agents
- Use of potassium-sparing diuretics
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 |
|---|---|---|
| TacrolimusAlso: Prograf, FK506oral | Drug | Tacrolimus group |
| Placebooral | Drug | Placebo |
Primary outcome
Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio)
Time frame: Week 0, week 12 and week 16
6 secondary outcomes
Proportion of subjects achieving more than 30% reduction of UACR level from baseline
Time frame: Week 0 and week 16
Proportion of subjects achieving more than 50% reduction of UACR level from baseline
Time frame: Week 0 and week 16
Proportion of subjects achieving more than 0.2 reduction of UACR level
Time frame: Week 0 and week 16
Composite event rate achieving less than 0.2 or 50% reduction of UACR level
Time frame: Week 0 and week 16
Changes of UACR measured between before the study and each visit
Time frame: Week 0, week 4, week 8, week 12 and week 16
Incidence of adverse events according to subject's self-assessment, vital signs, investigator's assessment and labo-tests
Time frame: Through week 16
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 21 Aug 2014.
- Derived from this study: PubMed 23977072Kim YC, Chin HJ, Koo HS, Kim S. Tacrolimus decreases albuminuria in patients with IgA nephropathy and normal blood pressure: a double-blind randomized controlled trial of efficacy of tacrolimus on IgA nephropathy. PLoS One. 2013 Aug 19;8(8):e71545. doi: 10.1371/journal.pone.0071545. eCollection 2013.
Related trials for IgA Nephropathy
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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.
Use Central Contact study chair
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tacrolimus in people with IgA Nephropathy, run by Astellas Pharma Inc at 1 site in South Korea.
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 4 inclusion and 7 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 21 Aug 2014. 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 South Korea. 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. Some participants in this study may receive a placebo. 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 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?
Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio) (time frame: Week 0, week 12 and week 16). 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 NCT01224028, 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 21 Aug 2014.