Glomerulosclerosis, FocalPhase 1NCT00353535

Total Lymphoid Irradiation (TLI) to Prevent Focal Segmental Glomerulosclerosis (FSGS)Recurrence in the Renal Graft

A Phase 1 study testing Total Lymphoid irradiation in people with Glomerulosclerosis, Focal, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose was study the immunosuppression using total lymphoid irradiation plus Csa, MMF and prednisone pretransplant to prevent focal segmental glomerulosclerosis recurrence in the renal graft Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glomerulosclerosis, Focal
What is being tested?: Total Lymphoid irradiation
Type of treatment: Surgery or procedure
How many people: 10 participants
Where: 1 siteBrazil
Study dates: Jan 2000to Dec 2002
Phase: Phase 1
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

Patients (age > 18 years)
Biopsy-proven primary FSGS
End-stage renal failure at presentation or prior allograft loss due to recurrent FSGS.
Signed the informed consent before entering in the study.

Who cannot join

Age < or equal 18 years
No biopsy-proven FSGS
Without living donor to perform the transplant
No signed the informed consent

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital das Clinicas - Division of Urology and Radiotherapy - University of Sao Paulo
São Paulo, São Paulo, 05403-000

Other trials in Brazil

About this study

Official title: Phase 1 Study of TLI Pretransplant to Prevent Recurrence of FSGS in the Graft

The purpose was study the immunosuppression using total lymphoid irradiation plus Csa, MMF and prednisone pretransplant to prevent focal segmental glomerulosclerosis recurrence in the renal graft

Read the detailed description

Focal and segmental glomerulosclerosis (FSGS) is resistant to treatment with immunosuppressants and after transplant, 40% of such patients have recurrences in renal allograft. The purpose of this trial was to use Total Lymphoid Irradiation (TLI) plus mycophenolate mofetil (MMF), cyclosporine A (CsA) and prednisone (PRED) to prevent recurrence.

Conditions: Glomerulosclerosis, Focal
Being tested: Total Lymphoid irradiation
Keywords: glomerulosclerosis, focal, pretransplant immunosuppression, total lymphoid irradiation, renal transplant, recurrence
Medical subject headings: Glomerulosclerosis, Focal Segmental, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Total Lymphoid irradiationProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant

Secondary outcomes (1)

Morbidity and mortality ot the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2000Dec 2002

First posted18 Jul 2006 (estimated)
Study startJan 2000
Study completionDec 2002

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Glomerulosclerosis, FocalStudies of the same condition, open and under way.
More trials run by University of Sao PauloThe 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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00353535
Sponsor's protocol ID: TLIFSGSusp
Status last verified: Sep 2005
First submitted: 17 Jul 2006
Last updated: 18 Jul 2006
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomerulosclerosis
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
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
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
Not yet recruitingPhase 2
A Study to Evaluate the Effectiveness and Safety of Sibeprenlimab in Participants With Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, and Minimal Change Disease
Primary Membranous Nephropathy, Minimal Change Disease

All Glomerulosclerosis, Focal trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1 Study of TLI Pretransplant to Prevent Recurrence of FSGS in the Graft
ClinicalTrials.gov ID: NCT00353535
Acronym / sponsor ID: TLIFSGSusp
Conditions: Glomerulosclerosis, Focal
Keywords: glomerulosclerosis, focal, pretransplant immunosuppression, total lymphoid irradiation, renal transplant, recurrence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants
Lead sponsor: University of Sao PauloUniversity, hospital or other
Study start: Jan 2000
Study completion: Dec 2002
First posted: 18 Jul 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 was study the immunosuppression using total lymphoid irradiation plus Csa, MMF and prednisone pretransplant to prevent focal segmental glomerulosclerosis recurrence in the renal graft

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients (age > 18 years)
Biopsy-proven primary FSGS
End-stage renal failure at presentation or prior allograft loss due to recurrent FSGS.
Signed the informed consent before entering in the study.

Key exclusion criteria (4 listed)

Age < or equal 18 years
No biopsy-proven FSGS
Without living donor to perform the transplant
No signed the informed consent

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
Total Lymphoid irradiation	Procedure or surgery	–

Primary outcome

Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant

1 secondary outcome

Morbidity and mortality ot the treatment

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 18 Jul 2006.

Related trials for Glomerulosclerosis, Focal

RecruitingPhase 3
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomerulosclerosis
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
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
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
Not yet recruitingPhase 2
A Study to Evaluate the Effectiveness and Safety of Sibeprenlimab in Participants With Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, and Minimal Change Disease
Primary Membranous Nephropathy, Minimal Change Disease

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.

Pedro Chocair, Prof. PhD principal investigator

Renal Transplant Unity - Hospital das Clinicas - Medicine School - University of Sao Paulo - Brazil

Rosangela Villar, MD principal investigator

Assistent doctor and Medical Supervisor of Division of Radiotherapy - Institute of Radiology - Hospital das Clinicas - University of Sao Paulo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Total Lymphoid irradiation in people with Glomerulosclerosis, Focal, run by University of Sao Paulo at 1 site in Brazil.

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 4 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 18 Jul 2006. 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 Brazil. 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 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.

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?

Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant. 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 NCT00353535.

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 18 Jul 2006.