Nephrotic SyndromePhase 1/2NCT02455908
IL-2 for Multi Drug Resistant Nephrotic Syndrome
A Phase 1/2 study testing Proleukin® in people with Nephrotic Syndrome, run by Istituto Giannina Gaslini at 1 site in Italy.
Trial summary
The aim of the study is to design an open-label phase 1-2 trial to assess safety and clinical and immunologic effects of repeated administration of recombinant low dose IL2 (Proleukin) in 5 patients with idiopathic nephrotic syndrome unresponsive to drugs (steroids, calcineurin inhibitors, Rituximab), following the… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- Proleukin®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2012to Aug 2012
- Phase
- Phase 1/2
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Drug resistance: persistence of proteinuria in nephrotic range after a cycle of steroids of at least 3 months and an association with cyclosporine/tacrolimus for at least other 6 months
- Parents'/guardian's written informed consent, and child's assent given before any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care.
- Age between 2 and 18 years
- Histological pattern of minimal change disease, mesangial proliferation with IgM deposits or focal segmental glomerulosclerosis
Who cannot join
- Positivity to autoimmunity tests (ANA, dsDNA, ANCA).
- Reduction of C3 levels.
- Hystological pattern characterized by elements suggestive for congenital disease: diffuse mesangial sclerosis without IgM deposits, cystic-like tubular dilatation, mitochondrial abnormalities evident on electron microscopy, IF suggestive for congenital collagen 4 disease.
- Histological pattern not suitable with INS in the pediatric age (membranous glomerulonephritis, lupus nephritis, diffuse and/or localized vasculitis, amyloidosis)
- Homozygous or heterozygous mutations of to the 3 genes (NPHS1, NPHS2, WT1) whose mutations are known to be responsible of almost 80% of familiar cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of IL-2 for Pediatric, Multi Drug Resistant, Idiopathic Nephrotic Syndrome
The aim of the study is to design an open-label phase 1-2 trial to assess safety and clinical and immunologic effects of repeated administration of recombinant low dose IL2 (Proleukin) in 5 patients with idiopathic nephrotic syndrome unresponsive to drugs (steroids, calcineurin inhibitors, Rituximab), following the therapeutical scheme indicated for crioglobulinemic nephropathy:
cycle1: IL2 1x106 /m2 s.c for 5 consecutive days cycle2: IL2 1.5 x106 / m2 s.c for 5 consecutive days, starting from 3 weeks after the first cycle.
Read more
cycle3: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 6 weeks after the first cycle.
Cycle 4: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 9 weeks after the first cycle.
Current therapy with steroids and calcineurin inhibitors (Prograf) will be maintained during the first cycle and progressively reduced during the subsequent cycles.
The first cycle will be performed during hospitalization in the investigators Unit; subsequent cycles will be performed at nephrology outpatients. All laboratory values normally utilized in the follow up of patients affected by idiopathic nephrotic syndrome will be evaluated during the first week of treatment and at the end of the protocol, together with specific cellular values (Tregs, B cells, NK).
- Conditions
- Nephrotic Syndrome
- Being tested
- Proleukin®
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proleukin®Drug
Also called IL-2
| Study group | Role | What they receive |
|---|---|---|
| Proleukin® | Experimental | Subcutaneous administration of low doses of IL2 (Proleukin) following the therapeutical scheme indicated for crioglobulinemic nephropathy:
cycle1: IL2 1x106 /m2 s.c for 5 consecutive days cycle2: IL2 1.5 x106 / m2 s.c for 5 consecutive days, starting from 3 weeks after the first cycle.
cycle3: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 6 weeks after the first cycle.
Cycle 4: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 9 weeks after the first cycle. Receives: Drug: Proleukin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteinuria
Complete remission is defined by urinary protein/creatinine ratio (uPCR) <200 mg/g (<20mg/mmol) for 3 consecutive days. Partial remission is defined as proteinuria reduction of 50% or greater from the presenting value and absolute uPCR between 200 and 2000 mg/g. for 3 consecutive days.
Measured: Change from baseline at 30, 60 and 180 days after first cycle (5 days)
Secondary outcomes (3)
Tregs Levels
Measured: Immediately before first cycle and 30, 60 and 180 days after first cycle (5 days)
Serum Creatinine
Measured: Change from baseline at 30, 60 and 180 days after first cycle (5 days)
Adverse events
Measured: From day 1 to day 5 of each cycle. The study includes 5 cycles, each one lasting 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Nephrotic SyndromeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gian Marco Ghiggeri MD, PhD, Istituto Giannina Gaslini
- Investigators
- Gian Marco Ghiggeri, MD, Principal investigator, Istituto Giannina Gaslini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455908
- Sponsor's protocol ID
- IL-2 off label
- Status last verified
- May 2015
- First submitted
- 13 May 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Trompeter RS, Lloyd BW, Hicks J, White RH, Cameron JS. Long-term outcome for children with minimal-change nephrotic syndrome. Lancet. 1985 Feb 16;1(8425):368-70. doi: 10.1016/s0140-6736(85)91387-x.
PubMed 2857421Sanna-Cherchi S, Caridi G, Weng PL, Scolari F, Perfumo F, Gharavi AG, Ghiggeri GM. Genetic approaches to human renal agenesis/hypoplasia and dysplasia. Pediatr Nephrol. 2007 Oct;22(10):1675-84. doi: 10.1007/s00467-007-0479-1. Epub 2007 Apr 17.
PubMed 17437132Pollak MR. Familial FSGS. Adv Chronic Kidney Dis. 2014 Sep;21(5):422-5. doi: 10.1053/j.ackd.2014.06.001.
PubMed 25168831Vincenti F, Ghiggeri GM. New insights into the pathogenesis and the therapy of recurrent focal glomerulosclerosis. Am J Transplant. 2005 Jun;5(6):1179-85. doi: 10.1111/j.1600-6143.2005.00968.x.
PubMed 15888021Reiser J, von Gersdorff G, Loos M, Oh J, Asanuma K, Giardino L, Rastaldi MP, Calvaresi N, Watanabe H, Schwarz K, Faul C, Kretzler M, Davidson A, Sugimoto H, Kalluri R, Sharpe AH, Kreidberg JA, Mundel P. Induction of B7-1 in podocytes is associated with nephrotic syndrome. J Clin Invest. 2004 May;113(10):1390-7. doi: 10.1172/JCI20402.
PubMed 15146236Bertelli R, Bodria M, Nobile M, Alloisio S, Barbieri R, Montobbio G, Patrone P, Ghiggeri GM. Regulation of innate immunity by the nucleotide pathway in children with idiopathic nephrotic syndrome. Clin Exp Immunol. 2011 Oct;166(1):55-63. doi: 10.1111/j.1365-2249.2011.04441.x. Epub 2011 Jul 15.
PubMed 21762125Ghiggeri GM, Cercignani G, Ginevri F, Bertelli R, Zetta L, Greco F, Candiano G, Trivelli A, Gusmano R. Puromycin aminonucleoside metabolism by glomeruli and glomerular epithelial cells in vitro. Kidney Int. 1991 Jul;40(1):35-42. doi: 10.1038/ki.1991.176.
PubMed 1921153Ginevri F, Gusmano R, Oleggini R, Acerbo S, Bertelli R, Perfumo F, Cercignani G, Allegrini S, D'Allegri F, Ghiggeri G. Renal purine efflux and xanthine oxidase activity during experimental nephrosis in rats: difference between puromycin aminonucleoside and adriamycin nephrosis. Clin Sci (Lond). 1990 Mar;78(3):283-93. doi: 10.1042/cs0780283.
PubMed 2156648Garin EH, Diaz LN, Mu W, Wasserfall C, Araya C, Segal M, Johnson RJ. Urinary CD80 excretion increases in idiopathic minimal-change disease. J Am Soc Nephrol. 2009 Feb;20(2):260-6. doi: 10.1681/ASN.2007080836. Epub 2008 Dec 3.
PubMed 19056875Le Berre L, Bruneau S, Naulet J, Renaudin K, Buzelin F, Usal C, Smit H, Condamine T, Soulillou JP, Dantal J. Induction of T regulatory cells attenuates idiopathic nephrotic syndrome. J Am Soc Nephrol. 2009 Jan;20(1):57-67. doi: 10.1681/ASN.2007111244. Epub 2008 Nov 19.
PubMed 19020006Wang YM, Zhang GY, Hu M, Polhill T, Sawyer A, Zhou JJ, Saito M, Watson D, Wu H, Wang Y, Wang XM, Wang Y, Harris DC, Alexander SI. CD8+ regulatory T cells induced by T cell vaccination protect against autoimmune nephritis. J Am Soc Nephrol. 2012 Jun;23(6):1058-67. doi: 10.1681/ASN.2011090914. Epub 2012 Apr 5.
PubMed 22491420Bertelli R, Di Donato A, Cioni M, Grassi F, Ikehata M, Bonanni A, Rastaldi MP, Ghiggeri GM. LPS nephropathy in mice is ameliorated by IL-2 independently of regulatory T cells activity. PLoS One. 2014 Oct 24;9(10):e111285. doi: 10.1371/journal.pone.0111285. eCollection 2014.
PubMed 25343479Polhill T, Zhang GY, Hu M, Sawyer A, Zhou JJ, Saito M, Webster KE, Wang Y, Wang Y, Grey ST, Sprent J, Harris DC, Alexander SI, Wang YM. IL-2/IL-2Ab complexes induce regulatory T cell expansion and protect against proteinuric CKD. J Am Soc Nephrol. 2012 Aug;23(8):1303-8. doi: 10.1681/ASN.2011111130. Epub 2012 Jun 7.
PubMed 22677553Saadoun D, Rosenzwajg M, Joly F, Six A, Carrat F, Thibault V, Sene D, Cacoub P, Klatzmann D. Regulatory T-cell responses to low-dose interleukin-2 in HCV-induced vasculitis. N Engl J Med. 2011 Dec 1;365(22):2067-77. doi: 10.1056/NEJMoa1105143.
PubMed 22129253Koreth J, Matsuoka K, Kim HT, McDonough SM, Bindra B, Alyea EP 3rd, Armand P, Cutler C, Ho VT, Treister NS, Bienfang DC, Prasad S, Tzachanis D, Joyce RM, Avigan DE, Antin JH, Ritz J, Soiffer RJ. Interleukin-2 and regulatory T cells in graft-versus-host disease. N Engl J Med. 2011 Dec 1;365(22):2055-66. doi: 10.1056/NEJMoa1108188.
PubMed 22129252
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of IL-2 for Pediatric, Multi Drug Resistant, Idiopathic Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT02455908
- Acronym / sponsor ID
- IL-2 off label
- Conditions
- Nephrotic Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 28 May 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.
The aim of the study is to design an open-label phase 1-2 trial to assess safety and clinical and immunologic effects of repeated administration of recombinant low dose IL2 (Proleukin) in 5 patients with idiopathic nephrotic syndrome unresponsive to drugs (steroids, calcineurin inhibitors, Rituximab), following the therapeutical scheme indicated for crioglobulinemic nephropathy:
cycle1: IL2 1x106 /m2 s.c for 5 consecutive days cycle2: IL2 1.5 x106 / m2 s.c for 5 consecutive days, starting from 3 weeks after the first cycle.
cycle3: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 6 weeks after the first cycle.
Cycle 4: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 9 weeks after the first cycle.
Current therapy with steroids and calcineurin inhibitors (Prograf) will be maintained during the first cycle and progressively reduced during the subsequent cycles.
The first cycle will be performed during hospitalization in the investigators Unit; subsequent cycles will be performed at nephrology outpatients. All laboratory values normally utilized in the follow up of patients affected by idiopathic nephrotic syndrome will be evaluated during the first week of treatment and at the end of the protocol, together with specific cellular values (Tregs, B cells, NK).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proleukin® | Experimental | Drug: Proleukin®Subcutaneous administration of low doses of IL2 (Proleukin) following the therapeutical scheme indicated for crioglobulinemic nephropathy: cycle1: IL2 1x106 /m2 s.c for 5 consecutive days cycle2: IL2 1.5 x106 / m2 s.c for 5 consecutive days, starting from 3 weeks after the first cycle. cycle3: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 6 weeks after the first cycle. Cycle 4: IL2 1.5 x106 /m2 s.c for 5 consecutive days, starting from 9 weeks after the first cycle. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Drug resistance: persistence of proteinuria in nephrotic range after a cycle of steroids of at least 3 months and an association with cyclosporine/tacrolimus for at least other 6 months
- Parents'/guardian's written informed consent, and child's assent given before any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care.
- Age between 2 and 18 years
- Histological pattern of minimal change disease, mesangial proliferation with IgM deposits or focal segmental glomerulosclerosis
Key exclusion criteria (5 listed)
- Positivity to autoimmunity tests (ANA, dsDNA, ANCA).
- Reduction of C3 levels.
- Hystological pattern characterized by elements suggestive for congenital disease: diffuse mesangial sclerosis without IgM deposits, cystic-like tubular dilatation, mitochondrial abnormalities evident on electron microscopy, IF suggestive for congenital collagen 4 disease.
- Histological pattern not suitable with INS in the pediatric age (membranous glomerulonephritis, lupus nephritis, diffuse and/or localized vasculitis, amyloidosis)
- Homozygous or heterozygous mutations of to the 3 genes (NPHS1, NPHS2, WT1) whose mutations are known to be responsible of almost 80% of familiar cases
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 |
|---|---|---|
| Proleukin®Also: IL-2 | Drug | Proleukin® |
Primary outcome
Proteinuria
Time frame: Change from baseline at 30, 60 and 180 days after first cycle (5 days)
Complete remission is defined by urinary protein/creatinine ratio (uPCR) <200 mg/g (<20mg/mmol) for 3 consecutive days. Partial remission is defined as proteinuria reduction of 50% or greater from the presenting value and absolute uPCR between 200 and 2000 mg/g. for 3 consecutive days.
3 secondary outcomes
Tregs Levels
Time frame: Immediately before first cycle and 30, 60 and 180 days after first cycle (5 days)
Serum Creatinine
Time frame: Change from baseline at 30, 60 and 180 days after first cycle (5 days)
Adverse events
Time frame: From day 1 to day 5 of each cycle. The study includes 5 cycles, each one lasting 5 days.
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 28 May 2015.
- Background: PubMed 2857421Trompeter RS, Lloyd BW, Hicks J, White RH, Cameron JS. Long-term outcome for children with minimal-change nephrotic syndrome. Lancet. 1985 Feb 16;1(8425):368-70. doi: 10.1016/s0140-6736(85)91387-x.
- Background: PubMed 17437132Sanna-Cherchi S, Caridi G, Weng PL, Scolari F, Perfumo F, Gharavi AG, Ghiggeri GM. Genetic approaches to human renal agenesis/hypoplasia and dysplasia. Pediatr Nephrol. 2007 Oct;22(10):1675-84. doi: 10.1007/s00467-007-0479-1. Epub 2007 Apr 17.
- Background: PubMed 25168831Pollak MR. Familial FSGS. Adv Chronic Kidney Dis. 2014 Sep;21(5):422-5. doi: 10.1053/j.ackd.2014.06.001.
- Background: PubMed 15888021Vincenti F, Ghiggeri GM. New insights into the pathogenesis and the therapy of recurrent focal glomerulosclerosis. Am J Transplant. 2005 Jun;5(6):1179-85. doi: 10.1111/j.1600-6143.2005.00968.x.
- Background: PubMed 15146236Reiser J, von Gersdorff G, Loos M, Oh J, Asanuma K, Giardino L, Rastaldi MP, Calvaresi N, Watanabe H, Schwarz K, Faul C, Kretzler M, Davidson A, Sugimoto H, Kalluri R, Sharpe AH, Kreidberg JA, Mundel P. Induction of B7-1 in podocytes is associated with nephrotic syndrome. J Clin Invest. 2004 May;113(10):1390-7. doi: 10.1172/JCI20402.
- Background: PubMed 21762125Bertelli R, Bodria M, Nobile M, Alloisio S, Barbieri R, Montobbio G, Patrone P, Ghiggeri GM. Regulation of innate immunity by the nucleotide pathway in children with idiopathic nephrotic syndrome. Clin Exp Immunol. 2011 Oct;166(1):55-63. doi: 10.1111/j.1365-2249.2011.04441.x. Epub 2011 Jul 15.
- Background: PubMed 1921153Ghiggeri GM, Cercignani G, Ginevri F, Bertelli R, Zetta L, Greco F, Candiano G, Trivelli A, Gusmano R. Puromycin aminonucleoside metabolism by glomeruli and glomerular epithelial cells in vitro. Kidney Int. 1991 Jul;40(1):35-42. doi: 10.1038/ki.1991.176.
- Background: PubMed 2156648Ginevri F, Gusmano R, Oleggini R, Acerbo S, Bertelli R, Perfumo F, Cercignani G, Allegrini S, D'Allegri F, Ghiggeri G. Renal purine efflux and xanthine oxidase activity during experimental nephrosis in rats: difference between puromycin aminonucleoside and adriamycin nephrosis. Clin Sci (Lond). 1990 Mar;78(3):283-93. doi: 10.1042/cs0780283.
- Background: PubMed 19056875Garin EH, Diaz LN, Mu W, Wasserfall C, Araya C, Segal M, Johnson RJ. Urinary CD80 excretion increases in idiopathic minimal-change disease. J Am Soc Nephrol. 2009 Feb;20(2):260-6. doi: 10.1681/ASN.2007080836. Epub 2008 Dec 3.
- Background: PubMed 19020006Le Berre L, Bruneau S, Naulet J, Renaudin K, Buzelin F, Usal C, Smit H, Condamine T, Soulillou JP, Dantal J. Induction of T regulatory cells attenuates idiopathic nephrotic syndrome. J Am Soc Nephrol. 2009 Jan;20(1):57-67. doi: 10.1681/ASN.2007111244. Epub 2008 Nov 19.
- Background: PubMed 22491420Wang YM, Zhang GY, Hu M, Polhill T, Sawyer A, Zhou JJ, Saito M, Watson D, Wu H, Wang Y, Wang XM, Wang Y, Harris DC, Alexander SI. CD8+ regulatory T cells induced by T cell vaccination protect against autoimmune nephritis. J Am Soc Nephrol. 2012 Jun;23(6):1058-67. doi: 10.1681/ASN.2011090914. Epub 2012 Apr 5.
- Background: PubMed 25343479Bertelli R, Di Donato A, Cioni M, Grassi F, Ikehata M, Bonanni A, Rastaldi MP, Ghiggeri GM. LPS nephropathy in mice is ameliorated by IL-2 independently of regulatory T cells activity. PLoS One. 2014 Oct 24;9(10):e111285. doi: 10.1371/journal.pone.0111285. eCollection 2014.
Related trials for Nephrotic Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
Nephrotic Syndrome, Proteinuria
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
Enrolling by invitationObservational study
Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center
Chronic Kidney Disease, Glomerulopathy
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.
Gian Marco Ghiggeri, MD principal investigator
Istituto Giannina Gaslini
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Proleukin® in people with Nephrotic Syndrome, run by Istituto Giannina Gaslini at 1 site in Italy.
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 5 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 28 May 2015. 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 Italy. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Proteinuria (time frame: Change from baseline at 30, 60 and 180 days after first cycle (5 days)). 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 NCT02455908, which also lists 23 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 28 May 2015.