Diabetic NephropathiesPhase 4PenDaNtNCT06224790
Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy
A Phase 4 study testing Pirfenidone in people with Diabetic Nephropathies and Type 2 Diabetes, run by Sidrah Lodhi at 1 site in Pakistan.
Trial summary
The purpose of this study is to determine the effectiveness \& safety of pirfenidone in type 2 diabetic patients with diabetic nephropathy Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetic Nephropathies, Type 2 Diabetes
- What is being tested?
- Pirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Mar 2024to 7 Mar 2025
- Phase
- Phase 4
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic Nephropathy Stage 3 (eGFR 30-59 mL/min/1.73m2) Type 2 Diabetes HbA1c <7.5% Patient taking ACEi/ARB for at least 3 months BP <140/90
Who cannot join
- History of photosensitivity rash History of decompensated liver or cardiac disease History of urinary tract infection Pregnancy or lactation History of nephrotoxic drugs or hakeem medication Polycystic kidney disease History of autoimmune disease History of hypersensitivity to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness & Safety of Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy: A Randomized Controlled Trial
The purpose of this study is to determine the effectiveness \& safety of pirfenidone in type 2 diabetic patients with diabetic nephropathy
- Conditions
- Diabetic Nephropathies, Type 2 Diabetes
- Being tested
- Pirfenidone, Placebo
- Keywords
- Type 2 Diabetes Mellitus, Diabetic Nephropathy, Perfenidone
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
Capsule Pirfenidone 1200mg/ day in divided doses for 3 months
PlaceboOther
2 Capsules 3 times a day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Group A (Pirfenidone) | Experimental | Capsule Pirfenidone 200mg, 2 X 8hrly for 3 months Receives: Drug: Pirfenidone |
| Group B | Placebo comparator | Placebo capsules - 2 X 8hrly for 3 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
15% improvement in eGFR
eGFR of the patients shall be evaluated for at least 15% improvement
Measured: 6 months
Secondary outcomes (1)
Safety - Adverse Effects of Drugs
Adverse Effects of the drugs
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start10 Mar 2024
- Primary completion7 Mar 2025
- Study completion7 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidrah Lodhi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sidrah Lodhi, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224790
- Sponsor's protocol ID
- 483/RC/KEMU/2022
- Acronym
- PenDaNt
- Status last verified
- Mar 2025
- First submitted
- 16 Jan 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness & Safety of Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06224790
- Acronym / sponsor ID
- PenDaNt / 483/RC/KEMU/2022
- Conditions
- Diabetic Nephropathies, Type 2 Diabetes
- Keywords
- Type 2 Diabetes Mellitus, Diabetic Nephropathy, Perfenidone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sidrah LodhiUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 25 Jan 2024 (actual)
- 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 determine the effectiveness \& safety of pirfenidone in type 2 diabetic patients with diabetic nephropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Pirfenidone) | Experimental | Drug: PirfenidoneCapsule Pirfenidone 200mg, 2 X 8hrly for 3 months |
| Group B | Placebo comparator | Other: PlaceboPlacebo capsules - 2 X 8hrly for 3 months |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic Nephropathy Stage 3 (eGFR 30-59 mL/min/1.73m2) Type 2 Diabetes HbA1c <7.5% Patient taking ACEi/ARB for at least 3 months BP <140/90
Key exclusion criteria (1 listed)
- History of photosensitivity rash History of decompensated liver or cardiac disease History of urinary tract infection Pregnancy or lactation History of nephrotoxic drugs or hakeem medication Polycystic kidney disease History of autoimmune disease History of hypersensitivity to study drugs
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 |
|---|---|---|
| PirfenidoneCapsule Pirfenidone 1200mg/ day in divided doses for 3 months | Drug | Group A (Pirfenidone) |
| Placebo2 Capsules 3 times a day for 3 months | Other | Group B |
Primary outcome
15% improvement in eGFR
Time frame: 6 months
eGFR of the patients shall be evaluated for at least 15% improvement
1 secondary outcome
Safety - Adverse Effects of Drugs
Time frame: 6 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 11 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetic Nephropathies
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pirfenidone in people with Diabetic Nephropathies and Type 2 Diabetes, run by Sidrah Lodhi at 1 site in Pakistan.
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 1 inclusion and 1 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 11 Mar 2025. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
15% improvement in eGFR (time frame: 6 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 11 Mar 2025.