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Montelukast for Kidney Disease in Type 1 Diabetes
Study Summary
This trial will explore if a drug to block inflammation can slow the progression of kidney disease in people with type 1 diabetes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2005 Phase 4 trial • 99 Patients • NCT00189462Trial Design
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Who is running the clinical trial?
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- You have a serious mental health condition in your past.I am between 18 and 80 years old.You have other serious health problems that make it likely for you to live less than 1 year.I have had Type 1 diabetes for 5 years or more.My liver is severely damaged.My kidney function is moderately reduced.I am currently using inhaled or systemic corticosteroids or long-acting beta agonists.The ratio of albumin to creatinine in your urine is between 30 and 5000 mg/g in your first morning urine sample.My blood pressure medication has not changed in the last month.I have been on a stable dose of ACE inhibitor or ARB for 4 weeks.I exercise vigorously no more than 2 days a week.My high blood pressure is not under control.I am currently taking phenobarbital, rifampin, or carbamazepine.I have been on a stable insulin regimen for at least 4 weeks.Anything that might make it hard for you to follow the study's treatments.Your blood pressure should be lower than 140/90 mm Hg before starting the study.Your body mass index (BMI) is less than 40.I expect to start dialysis or have a kidney transplant soon.You are allergic to penicillin.You are allergic to aspirin.You are allergic to iodine.You are allergic to shellfish.
- Group 1: Placebo
- Group 2: Montelukast
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Does the protocol for this experiment extend to elderly individuals?
"To be considered for this medical trial, participants must meet the stipulated age criteria; 18 being the youngest accepted and 80 representing a hard upper limit."
To what extent might the use of Montelukast be hazardous for patients?
"Because this medication has been approved, our team at Power gave Montelukast a score of 3 for safety on the 1-3 scale."
How many participants are currently enrolled in this research project?
"Affirmative. Unveiling the information present on clinicaltrials.gov, we can confirm that this medical study is actively recruiting participants since it was first posted on January 26th 2023 and last updated on April 18th 2023. The trial seeks a total of 50 individuals at 1 particular site to complete the research project."
Are there still opportunities to participate in this experiment?
"Affirmative. According to the info on clinicaltrials.gov, recruitment for this trial is in progress and began on January 26th, 2023. The most recent update was made April 18th, 2023 and up to 50 patients are being accepted from a single site."
May I submit my application to join this experiment?
"This research project is recruiting 50 adults aged between 18 and 80 that present with proteinuria. The primary qualifications for enrolment are: Age (18-80 years old), Type 1 diabetes diagnosis for at least five years, Urine albumin to creatinine ratio in the range of 30 - 5000 mg/g upon initial morning urination, eGFR rating from 30 - 89 ml/min/1.73m2 during screening process, Blood pressure reading below 140/90 mm Hg prior to randomization, Use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker for a minimum period of four weeks"
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