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PPAR Agonist
Saroglitazar for Kidney Failure
Phase 1
Recruiting
Led By Dr. Eric Lawitz, MD
Research Sponsored by Zydus Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to swallow and retain oral medication
Laboratory test values for severe renal impairment subjects must be clinically acceptable to the Investigator and meet all of the following parameters at screening: ALT value ≤ 3 × ULN, AST value ≤ 3 × ULN, Absolute neutrophil count (ANC) ≥ 750/mm3, Platelets ≥ 50,000/mm3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before dosing on day 1 through day 12
Awards & highlights
Study Summary
This trial will test a new drug in people with normal or impaired kidney function.
Who is the study for?
Adults aged 18-80 with either normal kidney function or severe renal impairment (not on dialysis, eGFR <30) can join. They must be able to take oral meds, have a BMI of 18-48 kg/m2, and use effective contraception if applicable. Exclusions include unstable medical conditions, recent malignancies except certain cancers, drug/alcohol abuse, HIV/HBV/HCV infection, major surgeries within specific timeframes.Check my eligibility
What is being tested?
The study is testing Saroglitazar Magnesium's effects in people with different levels of kidney health. It's an open-label Phase 1 trial where participants are openly given the medication to understand how it behaves in bodies with normal vs severely impaired kidneys.See study design
What are the potential side effects?
While not specified here, typical side effects for similar medications may include digestive issues like nausea or diarrhea; changes in blood sugar levels; fatigue; possible liver enzyme alterations; and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow and keep down pills.
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My kidney function tests and blood counts are within acceptable ranges.
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I am between 18 and 80 years old.
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My kidney function is normal, with an eGFR of 90 or above.
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I am between 18 and 80 years old.
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I can swallow and keep down pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before dosing on day 1 through day 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before dosing on day 1 through day 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUC from time zero to infinity (AUC0-∞)
AUC from time zero to the last quantifiable concentration (AUC0-t)
CL/F
+4 moreSecondary outcome measures
Incidence of AEs
Unbound Fraction
Unbound concentration
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Subjects (Normal renal function eGFR ≥90) will be matched according to age (± 10 years), sex, and weight (± 10 kg) with participants in Group 1 (Severe renal impairment not on HD) on a one to one basis based on demographic characteristic. Here, 8 participants will be administered single dose of 2 mg Saroglitazar Magnesium and 8 participants will be administered single dose of 4 mg Saroglitazar Magnesium.
Group II: Group 1Experimental Treatment1 Intervention
Subjects in severe renal impairment group will be enrolled and dosed consecutively (i.e. first 8 subjects of group 1 will receive 2 mg dose, followed by another 8 subjects who will receive 4 mg dose).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saroglitazar magnesium
2019
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
Zydus Therapeutics Inc.Lead Sponsor
13 Previous Clinical Trials
1,169 Total Patients Enrolled
Deven Parmar, MDStudy DirectorZydus Therapeutics Inc.
2 Previous Clinical Trials
190 Total Patients Enrolled
Dr. Eric Lawitz, MDPrincipal InvestigatorAmerican Research Corporation @ Texas Liver Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a kidney removal or transplant, recent dialysis, or significant lab result issues.I haven't had major stomach or intestinal surgery in the last 6 months.Your body mass index (BMI) is between 18.0 and 48.0.I can swallow and keep down pills.My heart's electrical activity is within a safe range, confirmed by tests.I have normal kidney function but a history of kidney issues.I haven't used any medication or products that change how drugs work in my body, including St. John's Wort, for the last 21 days.You tested positive for illegal drugs during screening.My kidney function, measured by eGFR, has been checked for changes.You have difficulty with getting blood drawn from your arm.I use or plan to use over-the-counter or prescription medications, but not for hormone replacement or stable renal treatments.I do not have liver disease or significant liver problems.I am not pregnant or breastfeeding and will use effective birth control during the study.My severe kidney condition has changed recently, as noted by my doctor.My kidney function tests and blood counts are within acceptable ranges.I am currently on treatment for an active infection.My kidney function is normal, and I match a Group 1 participant in age, sex, and weight.You have tested positive for HIV, Hepatitis B, or Hepatitis C.I am between 18 and 80 years old.I have not had a blood transfusion in the last 2 weeks.My kidney function, measured by eGFR, has been stable from screening to Day -1.I have not taken any medications except for vitamins, acetaminophen, contraceptives, or approved over-the-counter products in the last 14 days.My kidney function is normal, with an eGFR of 90 or above.I am in good health with normal kidney function and no significant medical issues.I am between 18 and 80 years old.I can swallow and keep down pills.I haven't had any cancer except for certain skin cancers or in situ cervical/breast cancer in the last 3 years.I have not donated blood or blood products in the last 3 months.I have not had major surgery in the last 3 months.I have severe kidney issues but my doctor thinks my condition is stable.Your body mass index (BMI) is between 18.0 and 48.0.I match in age, sex, and weight with someone who has severe kidney issues.You have had a serious allergic reaction to any medication that is important to your health, as determined by the doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2
- Group 2: Group 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity for me to partake in this experiment?
"The trial is enrolling 32 participants that have impaired renal function and meet the following conditions: Body mass index ranging from 18.0 - 48.0 kg/m2, patients in Group 2 must match those in Group 1 with regards to age (± 10 years), sex, and weight (± 10 kg). Additionally, candidates must be able to swallow oral medication, aged between 18-80 at signing of informed consent forms; Participants will then receive a classification based on their estimated glomerular filtration rate according to the modification of diet in renal disease formula for chronic kidney disease - if this differs at Day -1 they will still"
Answered by AI
Does this experiment accept elderly individuals as participants?
"Patients hoping to enroll in this study must be 18-80 years old, though there are 6 trials for minors and 158 specifically aimed at elderly patients."
Answered by AI
What is the intended outcome of this experiment?
"The clinical trial's primary endpoint is the area under the concentration-time curve between time zero and infinity (AUC0-∞). To evaluate drug safety, secondary outcomes cover adverse events incidence rate and severity, unbound plasma saroglitazar levels, and amount of medication excreted in urine."
Answered by AI
Are there vacancies available in this clinical experiment?
"Affirmative. As per the information on clinicaltrials.gov, this medical study is currently seeking participants. This trial was first made available to potential patients on July 27th 2020 and has been recently updated as of April 23rd 2022. At present 32 individuals are required for enrolment across a single location."
Answered by AI
How many individuals have been recruited for this exploration?
"Affirmative. Clinicaltrials.gov has information indicating that this experiment, which was first published on July 27th 2020, is actively enlisting participants. 32 individuals are required to be recruited from a single site."
Answered by AI
Has Saroglitazar magnesium been endorsed by the FDA?
"Our team at Power scored Saroglitazar magnesium's safety as a 1 due to the limited data available from Phase 1 trials that support its efficacy and security."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
American Research Corporation @ Texas Liver Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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