FibrosisPhase 1/2NCT02408744
Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
A Phase 1/2 study testing Pirfenidone in people with Fibrosis and Chronic Kidney Disease, run by University of Guadalajara.
Trial summary
The aim of this study was to evaluate the impact in safety and efficacy of a new formulation of prolonged-released Pirfenidone in the progression of renal damage in patients with Chronic kidney Disease (CKD). Read more about this study
- Who is it for?
- Ages 10 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibrosis, Chronic Kidney Disease
- What is being tested?
- Pirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Sep 2013
- 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 10 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients between 10 and 40 years old with CKD
- Diagnosis of CKD stage 1 to 4 according with KDIGO definition and classification
- No glucocorticoids, cyclophasphamide, mycophenolate, or other immunosuppressive drugs for at least two months before starting PFD administration
- Sign of consent forms
Who cannot join
- Known intolerance to PFD
- CKD stage V according with KDOQI classification
- Post-transplant patients
- History of peptic ulcer within six months
- History of cerebrovascular disease within six months
- Evidence of hepatic disease
- Pregnancy or breast feeding
- Malignancy
About this study
The aim of this study was to evaluate the impact in safety and efficacy of a new formulation of prolonged-released Pirfenidone in the progression of renal damage in patients with Chronic kidney Disease (CKD).
- Conditions
- Fibrosis, Chronic Kidney Disease
- Being tested
- Pirfenidone
- Keywords
- nephroprotection, pirfenidone, polymorphisms
- Medical subject headings
- Fibrosis, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
Also called 5-methyl-1-phenyl-2-(1H)-pyridone
Pirfenidone was supplied orally in the form of prolonged-released tablets according with body surface area (m2 BS) of each patient. The target dosage of PFD was 1200 mg two times a day (b.i.d.) for a full dosage of 2400 mg daily during three years. Therapy was initiated at 600 mg b.i.d. and escalated to full dosage after 3 weeks when symptoms were controlled.
| Study group | Role | What they receive |
|---|---|---|
| Pirfenidone | Experimental | Pirfenidone 1200 mg in the form of prolonged-released tablets, orally administered two times a day (b.i.d.) to yield a daily dose of 2400 mg during three years. Receives: Drug: Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the results of the use of Pirfenidone in the progression of renal damage in patients with Chronic Kidney Disease.
The progression of renal damage in patients with Chronic Kidney Disease was evaluated according to stages 1-4 of classification KDIGO.
Measured: three years
Secondary outcomes (1)
Effect of the use of Pirfenidone in renal function
The renal function was monitored by cystatin C, reciprocal of serum creatinine and creatinine clearance collection of 24 hrs.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibrosisStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Cell Therapy And Technology, S.a. De C.v.
- Responsible party
- Principal investigator, Juan Armendáriz-Borunda, University of Guadalajara
- Investigators
- Juan Armendariz-Borunda, Ph.D., Study director, Head, Molecular Biology and Genomics Department, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408744
- Sponsor's protocol ID
- Pirfenidona 001
- Status last verified
- Mar 2015
- First submitted
- 31 Mar 2015
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02408744
- Acronym / sponsor ID
- Pirfenidona 001
- Conditions
- Fibrosis, Chronic Kidney Disease
- Keywords
- nephroprotection, pirfenidone, polymorphisms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Collaborators
- Cell Therapy And Technology, S.a. De C.v.
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 3 Apr 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 this study was to evaluate the impact in safety and efficacy of a new formulation of prolonged-released Pirfenidone in the progression of renal damage in patients with Chronic kidney Disease (CKD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone | Experimental | Drug: PirfenidonePirfenidone 1200 mg in the form of prolonged-released tablets, orally administered two times a day (b.i.d.) to yield a daily dose of 2400 mg during three years. |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients between 10 and 40 years old with CKD
- Diagnosis of CKD stage 1 to 4 according with KDIGO definition and classification
- No glucocorticoids, cyclophasphamide, mycophenolate, or other immunosuppressive drugs for at least two months before starting PFD administration
- Sign of consent forms
Key exclusion criteria (8 listed)
- Known intolerance to PFD
- CKD stage V according with KDOQI classification
- Post-transplant patients
- History of peptic ulcer within six months
- History of cerebrovascular disease within six months
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 |
|---|---|---|
| PirfenidoneAlso: 5-methyl-1-phenyl-2-(1H)-pyridonePirfenidone was supplied orally in the form of prolonged-released tablets according with body surface area (m2 BS) of each patient. The target dosage of PFD was 1200 mg two times a day (b.i.d.) for a full dosage of 2400 mg daily during three years. Therapy was initiated at 600 mg b.i.d. and escalated to full dosage after 3 weeks when symptoms were controlled. | Drug | Pirfenidone |
Primary outcome
Evaluate the results of the use of Pirfenidone in the progression of renal damage in patients with Chronic Kidney Disease.
Time frame: three years
The progression of renal damage in patients with Chronic Kidney Disease was evaluated according to stages 1-4 of classification KDIGO.
1 secondary outcome
Effect of the use of Pirfenidone in renal function
Time frame: Three years
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 3 Apr 2015.
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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.
Juan Armendariz-Borunda, Ph.D. study director
Head, Molecular Biology and Genomics Department, University of Guadalajara
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pirfenidone in people with Fibrosis and Chronic Kidney Disease, run by University of Guadalajara.
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 8 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 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluate the results of the use of Pirfenidone in the progression of renal damage in patients with Chronic Kidney Disease. (time frame: three years). 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 3 Apr 2015.