IGA NephropathyPhase 2NCT00767221
Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study
A Phase 2 study testing Budesonide in people with IGA Nephropathy, run by Calliditas Therapeutics AB at 3 sites in Sweden.
Trial summary
The study will investigate the effect of PL-56 on albumin leakage and renal function (glomerular filtration rate) in patients with IgA nephropathy. It will also assess the safety of treatment with PL-56. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IGA Nephropathy
- What is being tested?
- Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesSweden
- Study dates
- Oct 2005to Nov 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Female or male patient > 18 years
- Biopsy-verified IgA nephropathy
- Proteinuria: U-albumin >500 mg/24 h
- S-creatinine < 200 umol/L
- A minimum of four available sample results (U-albumin and S-creatinine) prior to inclusion in the study.
Who cannot join
- Severe gastrointestinal disorders which may impair drug effect, or other conditions which could modify the effect of the trial drug as judged by the investigator
- Consumption of an investigational drug within 30 days prior to enrolment
- Unacceptable blood pressure (treated or untreated), defined as a systolic value >150 mm Hg and/or diastolic >90 mm Hg
- Hyperlipidaemia defined as unacceptable levels of lipids according to the discretion of the Investigator
- Patients in whom an ACE inhibitor was introduced/changed during the last three months prior to enrolment
- Patients treated with immuno-suppressive drugs
Show all 18Show fewer
- Patients unable to take oral medication
- Severe liver disease (defined as ASAT and/or ALAT and/or gamma-GT above twice the normal value).
- Uncontrolled (treated or untreated) congestive heart failure as judged by the Investigator
- Patients with diabetes
- Patients with current malignancy or history of malignancy during the last three years
- History or presence of psychological or psychiatric illness which may interfere with the patient´s ability to adhere to the protocol
- Alcohol or drug abuse (present)
- Patients unwilling to meet the requirements of the protocol
- Other medical or social reasons for exclusion at the discretion of the Investigator
- Use of drugs inhibiting the cytochrome P-450 enzyme CYP3A4 (including grape fruit juice)
- Kidney transplanted patients
- For women only: pregnant or breast feeding; unwilling to use adequate contraception during the study (only women of childbearing potential)
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Linköping University Hospital
Linköping
Huddinge University Hospital
Stockholm
Uppsala University Hospital
Uppsala
About this study
The study will investigate the effect of PL-56 on albumin leakage and renal function (glomerular filtration rate) in patients with IgA nephropathy. It will also assess the safety of treatment with PL-56.
- Conditions
- IGA Nephropathy
- Being tested
- Budesonide
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Also called Nefecon, PL-56 (topical acting, anti-inflammatory agent)
8 mg PL-56 once daily for six months
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | The patient is his own control. Endpoint variables are measured before, during and after treatment. Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
U-albumin
Measured: 6(treatment)+3(follow-up) months
Secondary outcomes (1)
GFR and safety
Measured: 6(treatment) + 3(follow-up) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startOct 2005
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calliditas Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Archimedes Development Ltd
- Investigators
- Bengt Fellström, MD, PhD, Principal investigator, Uppsala University Hospital, Dept. of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767221
- Sponsor's protocol ID
- U-03-003
- Status last verified
- Apr 2009
- First submitted
- 5 Oct 2008
- Last updated
- 21 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study
- ClinicalTrials.gov ID
- NCT00767221
- Acronym / sponsor ID
- U-03-003
- Conditions
- IGA Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Calliditas Therapeutics ABIndustry (pharma, biotech, devices)
- Collaborators
- Archimedes Development Ltd
- Study start
- Oct 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 7 Oct 2008 (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.
The study will investigate the effect of PL-56 on albumin leakage and renal function (glomerular filtration rate) in patients with IgA nephropathy. It will also assess the safety of treatment with PL-56.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: BudesonideThe patient is his own control. Endpoint variables are measured before, during and after treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent
- Female or male patient > 18 years
- Biopsy-verified IgA nephropathy
- Proteinuria: U-albumin >500 mg/24 h
- S-creatinine < 200 umol/L
Key exclusion criteria (18 listed)
- Severe gastrointestinal disorders which may impair drug effect, or other conditions which could modify the effect of the trial drug as judged by the investigator
- Consumption of an investigational drug within 30 days prior to enrolment
- Unacceptable blood pressure (treated or untreated), defined as a systolic value >150 mm Hg and/or diastolic >90 mm Hg
- Hyperlipidaemia defined as unacceptable levels of lipids according to the discretion of the Investigator
- Patients in whom an ACE inhibitor was introduced/changed during the last three months prior to enrolment
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 |
|---|---|---|
| BudesonideAlso: Nefecon, PL-56 (topical acting, anti-inflammatory agent)8 mg PL-56 once daily for six months | Drug | A |
Primary outcome
U-albumin
Time frame: 6(treatment)+3(follow-up) months
1 secondary outcome
GFR and safety
Time frame: 6(treatment) + 3(follow-up) 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 21 Apr 2009.
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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.
Bengt Fellström, MD, PhD principal investigator
Uppsala University Hospital, Dept. of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Budesonide in people with IGA Nephropathy, run by Calliditas Therapeutics AB at 3 sites in Sweden.
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 6 inclusion and 18 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 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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 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?
U-albumin (time frame: 6(treatment)+3(follow-up) months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2009.