Glomerulonephritis, IGAPhase 2SIREPNANCT00396721
Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy
A Phase 2 study testing ACE inhibitor + statin and Sirolimus (study drug)+ACE inhibitor + statin in people with Glomerulonephritis, IGA and Nephropathy, IGA, run by Josep m Cruzado at 1 site in Spain.
Trial summary
The purpose of this study is to test in a pilot trial the efficacy and tolerance of sirolimus oral (at low doses) in patient to treat poor-prognosis IgA Nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glomerulonephritis, IGA, Nephropathy, IGA, IGA Nephropathy
- What is being tested?
- ACE inhibitor + statin and Sirolimus (study drug)+ACE inhibitor + statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2006to Feb 2010
- 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
- Age 18 to 70 and with capacity to grant informed consent
- Biopsy-proven IgA nephropathy by means of standard immunohistochemical and morphological criteria
- Renal biopsy in the in the 3 months prior to randomization date
- Absence of known hepatic, cardiac, pulmonary or intestinal disease
- Glomerular filtrate estimated by Cockcroft-Gault, more than 30 ml/min
- Any of the following clinical states: a) High blood pressure defined as systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg associated with proteinuria between 0.3-1 g/day and/or microhematuria. b) Proteinuria higher than 1g/day
- Women of child-bearing age will follow a suitable contraceptive method, and a negative pregnancy test will be needed before inclusion in the study
Who cannot join
- Serology positive for HIV or hepatitis B infection (defined as positive for the HbsAg antigen) or hepatitis C infection (defined as viral RNA detection)
- Treatment with steroids or immunosuppressors in the two previous years
- Evidence of active infection at the time of inclusion in the study
- Pregnancy or breastfeeding at the time of inclusion in the study
- Estimated glomerular filtration < 30 ml/min, bilirubin > 2 mg/dl, or ALT or AST two times higher than the normal upper limit
- Diabetes Mellitus, defined as patients treated with insulin or oral antidiabetics or glycemias higher than 140 mg/dl in two or more episodes
Show all 11Show fewer
- Poor control of high blood pressure (defined as systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg, taking 3 or more antihypertensives) or evidence or suspicion of renovascular disease
- Thrombocytopenia less than 100,000 /mm3 or total neutrophil value lower than 2000 /mm3 or triglycerides value > 400 mg/dL (4.6 mmol/L) or cholesterol > 300 mg/dL (7.8 mmol/L) or LDL > 200 mg/dL
- IgA nephropathy systemic forms, i.e., Schönlein-Henoch purpura, IgA nephropathy secondary forms, post-renal transplant IgA nephropathy recurrences, cases presented in the form of rapidly progressive renal failure and cases with the presence of cellular crescents in more than 50% of the glomeruli will be excluded
- History of cancer in the previous 5 years,exception of skin basocellular carcinoma and uterine in situ carcinoma (completely removed both of them)
- Know intolerance to Sirolimus or macrolides
Trial locations and contacts
1 site in 1 country.
Spain1 site
Nephrology Department. Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Pilot Trial of Treatment of Poor-Prognosis IgA Nephropathy With Low Exposure to Sirolimus.
The purpose of this study is to test in a pilot trial the efficacy and tolerance of sirolimus oral (at low doses) in patient to treat poor-prognosis IgA Nephropathy.
- Conditions
- Glomerulonephritis, IGA, Nephropathy, IGA, IGA Nephropathy
- Being tested
- ACE inhibitor + statin, Sirolimus (study drug)+ACE inhibitor + statin
- Keywords
- Nephropathy, IGA, Pilot trial, Sirolimus, Rapamune
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE inhibitor + statinDrug
sirolimus starting at 1 mg/d (target 3-6 ng/ml) plus enalapril starting at 5 mg/d to control blood pressure plus atorvastatin starting at 10 mg/d
Sirolimus (study drug)+ACE inhibitor + statinDrug
enalapril starting at 5 mg/d in order to control blood pressure. Atorvastatin starting at 10 mg/d
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: ACE inhibitor + statin |
| B | Experimental | Not described Receives: Drug: Sirolimus (study drug)+ACE inhibitor + statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of the administration of Rapamune on a clinical composite variable (change in proteinuria, blood pressure and hematuria) in patients with IgA nephropathy with poor prognosis criteria
Measured: at month 12th
Secondary outcomes (4)
Change in the glomerular filtrate rate evaluated by means of radionuclide techniques (51Cr-EDTA) and comparison between both arms
Measured: At months 6th and 12th
Change in renal histology
Measured: At 12 months
Percentage of patients who withdraw from the study medication due to adverse events
Measured: Within 1 year
Percentage of patients with therapeutic failure
Measured: Within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study startJan 2006
- Primary completionOct 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Glomerulonephritis, IGAStudies 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
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josep m Cruzado
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor-investigator, Josep m Cruzado, Hospital Universitari de Bellvitge
- Investigators
- Josep M Cruzado, Medical Doctor, Study chair, Nephrlogy Department. Hospital Universitari de BellvitgeMeritxell Ibernon, MD, Principal investigator, Germans Trias i Pujol HospitalJORDI BALLARÍN, MD, Principal investigator, FUNDACIÓ PUIGVERT DE BARCELONA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396721
- Sponsor's protocol ID
- SIREPNA/05
- Other IDs
- 2005-002610-37, 2005
- Acronym
- SIREPNA
- Status last verified
- Sep 2011
- First submitted
- 3 Nov 2006
- Last updated
- 16 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Donadio JV, Grande JP. IgA nephropathy. N Engl J Med. 2002 Sep 5;347(10):738-48. doi: 10.1056/NEJMra020109. No abstract available.
PubMed 12213946Donadio JV Jr, Bergstralh EJ, Offord KP, Spencer DC, Holley KE. A controlled trial of fish oil in IgA nephropathy. Mayo Nephrology Collaborative Group. N Engl J Med. 1994 Nov 3;331(18):1194-9. doi: 10.1056/NEJM199411033311804.
PubMed 7935657Wu H, Clarkson AR, Knight JF. Restricted gammadelta T-cell receptor repertoire in IgA nephropathy renal biopsies. Kidney Int. 2001 Oct;60(4):1324-31. doi: 10.1046/j.1523-1755.2001.00937.x.
PubMed 11576346Bonegio RG, Fuhro R, Wang Z, Valeri CR, Andry C, Salant DJ, Lieberthal W. Rapamycin ameliorates proteinuria-associated tubulointerstitial inflammation and fibrosis in experimental membranous nephropathy. J Am Soc Nephrol. 2005 Jul;16(7):2063-72. doi: 10.1681/ASN.2004030180. Epub 2005 May 25.
PubMed 15917339
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Treatment of Poor-Prognosis IgA Nephropathy With Low Exposure to Sirolimus.
- ClinicalTrials.gov ID
- NCT00396721
- Acronym / sponsor ID
- SIREPNA / SIREPNA/05
- Conditions
- Glomerulonephritis, IGA, Nephropathy, IGA, IGA Nephropathy
- Keywords
- Nephropathy, IGA, Pilot trial, Sirolimus, Rapamune
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Josep m CruzadoUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Jan 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 7 Nov 2006 (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 purpose of this study is to test in a pilot trial the efficacy and tolerance of sirolimus oral (at low doses) in patient to treat poor-prognosis IgA Nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: ACE inhibitor + statin |
| B | Experimental | Drug: Sirolimus (study drug)+ACE inhibitor + statin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 70 and with capacity to grant informed consent
- Biopsy-proven IgA nephropathy by means of standard immunohistochemical and morphological criteria
- Renal biopsy in the in the 3 months prior to randomization date
- Absence of known hepatic, cardiac, pulmonary or intestinal disease
- Glomerular filtrate estimated by Cockcroft-Gault, more than 30 ml/min
Key exclusion criteria (11 listed)
- Serology positive for HIV or hepatitis B infection (defined as positive for the HbsAg antigen) or hepatitis C infection (defined as viral RNA detection)
- Treatment with steroids or immunosuppressors in the two previous years
- Evidence of active infection at the time of inclusion in the study
- Pregnancy or breastfeeding at the time of inclusion in the study
- Estimated glomerular filtration < 30 ml/min, bilirubin > 2 mg/dl, or ALT or AST two times higher than the normal upper limit
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 |
|---|---|---|
| ACE inhibitor + statinsirolimus starting at 1 mg/d (target 3-6 ng/ml) plus enalapril starting at 5 mg/d to control blood pressure plus atorvastatin starting at 10 mg/d | Drug | A |
| Sirolimus (study drug)+ACE inhibitor + statinenalapril starting at 5 mg/d in order to control blood pressure. Atorvastatin starting at 10 mg/d | Drug | B |
Primary outcome
To evaluate the effect of the administration of Rapamune on a clinical composite variable (change in proteinuria, blood pressure and hematuria) in patients with IgA nephropathy with poor prognosis criteria
Time frame: at month 12th
4 secondary outcomes
Change in the glomerular filtrate rate evaluated by means of radionuclide techniques (51Cr-EDTA) and comparison between both arms
Time frame: At months 6th and 12th
Change in renal histology
Time frame: At 12 months
Percentage of patients who withdraw from the study medication due to adverse events
Time frame: Within 1 year
Percentage of patients with therapeutic failure
Time frame: Within 1 year
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 Sep 2011.
- Background: PubMed 12213946Donadio JV, Grande JP. IgA nephropathy. N Engl J Med. 2002 Sep 5;347(10):738-48. doi: 10.1056/NEJMra020109. No abstract available.
- Background: PubMed 7935657Donadio JV Jr, Bergstralh EJ, Offord KP, Spencer DC, Holley KE. A controlled trial of fish oil in IgA nephropathy. Mayo Nephrology Collaborative Group. N Engl J Med. 1994 Nov 3;331(18):1194-9. doi: 10.1056/NEJM199411033311804.
- Background: PubMed 11576346Wu H, Clarkson AR, Knight JF. Restricted gammadelta T-cell receptor repertoire in IgA nephropathy renal biopsies. Kidney Int. 2001 Oct;60(4):1324-31. doi: 10.1046/j.1523-1755.2001.00937.x.
- Background: PubMed 15917339Bonegio RG, Fuhro R, Wang Z, Valeri CR, Andry C, Salant DJ, Lieberthal W. Rapamycin ameliorates proteinuria-associated tubulointerstitial inflammation and fibrosis in experimental membranous nephropathy. J Am Soc Nephrol. 2005 Jul;16(7):2063-72. doi: 10.1681/ASN.2004030180. Epub 2005 May 25.
- This is the center in Spain for the central contact and the main location including patients.Link provided by the sponsor.
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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.
Josep M Cruzado, Medical Doctor study chair
Nephrlogy Department. Hospital Universitari de Bellvitge
Meritxell Ibernon, MD principal investigator
Germans Trias i Pujol Hospital
JORDI BALLARÍN, MD principal investigator
FUNDACIÓ PUIGVERT DE BARCELONA
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 ACE inhibitor + statin and Sirolimus (study drug)+ACE inhibitor + statin in people with Glomerulonephritis, IGA and Nephropathy, IGA, run by Josep m Cruzado at 1 site in Spain.
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 7 inclusion and 11 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 Sep 2011. 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 Spain. 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?
To evaluate the effect of the administration of Rapamune on a clinical composite variable (change in proteinuria, blood pressure and hematuria) in patients with IgA nephropathy with poor prognosis criteria (time frame: at month 12th). 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 NCT00396721, which also lists 4 linked publications.
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 Sep 2011.