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Antibiotic

Pretomanid for Kidney Failure

Q: Does this experimental research include participants over the age of 65?

<p>To qualify for this medical trial, volunteers must be aged between 18-70. For those younger than 18, there are 56 different studies available and 297 trials catered to seniors over 65 years old.</p>

Phase 1

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject Inclusion Criteria for Healthy Subjects (Groups 1A-1C): Have the ability to understand the requirements of the study and have provided written informed consent before any study related procedure is performed. Agree to abide by the study restrictions. Are healthy male or non-pregnant female, between the ages of 18 and 70, inclusive, with normal GFR > / = 90 at screening. Are free from tobacco/nicotine usage (30-day minimum from screening visit). Have a normal QTc interval < 500 msecs on electrocardiogram (ECG). Have a body mass index of 18 to 35 kg/m^2. Women of childbearing potential must use an acceptable contraception method for the duration of the study. If subject is male and capable of reproduction, agrees to avoid fathering a child for the duration of the study by using an acceptable method of birth control. Women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to receipt of study product

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 12

Awards & highlights

Study Summary

This trial is a Phase I, open-label, single dose, sequential group study to compare the safety and pharmacokinetics of pretomanid in subjects with severe renal impairment including those with End Stage Renal Disease (ESRD) not needing dialysis, subjects with mild or moderate renal impairment, and subjects with normal renal function. The primary objective is to evaluate the PK profiles of pretomanid in plasma and urine after a single oral dose of 200 mg in subjects with renal impairment compared to matched healthy controls.

Who is the study for?

This trial is for adults aged 18-70 with varying degrees of kidney function, from normal to severe impairment, but not on dialysis. Participants must be non-smokers, have a healthy weight range (BMI 18-35), and a normal heart rhythm. Women should not be pregnant and must use birth control; men agree to prevent pregnancy during the study.Check my eligibility

What is being tested?

The study tests how a single dose of Pretomanid (PA-824) behaves in the body (its pharmacokinetics) in people with different levels of kidney health compared to those with normal kidneys. It involves taking one oral dose and monitoring its presence in blood and urine over three months.See study design

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to Pretomanid intake. This includes checking organ functions, vital signs, and overall health status throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Apparent clearance of drug from plasma after drug administration (CL/F)

Apparent first-order terminal elimination rate constant (Lambda z) of pretomanid

Apparent volume of distribution (Vd/F)

+8 more

Secondary outcome measures

Concentrations of pretonamid metabolites (M19 and M50) in plasma and urine

Excretion of representative metabolites M19 and M50 in urine

Alanine Transaminase

+14 more

Side effects data

From 2018 Phase 3 trial • 284 Patients • NCT02342886

31%

Arthralgia

31%

Pleuritic pain

23%

Neuropathy peripheral

15%

Nausea

15%

Abdominal pain

15%

Pulmonary embolism

15%

Headache

15%

Dizziness

15%

Vomiting

15%

Pruritus

15%

Hyperuricaemia

15%

Haemoptysis

Diarrhoea

Protein urine present

Burning sensation

Atrial fibrillation

Pneumonia

Myocarditis

Eyelid haematoma

Cardiac ventricular thrombosis

Alanine aminotransferase increased

Hypotension

Lower respiratory tract infection

Upper respiratory tract infection

Toothache

Pneumothorax spontaneous

Pulmonary oedema

Lung cancer metastatic

Left ventricular dysfunction

Blood uric acid increased

Myalgia

Pain in extremity

Musculoskeletal pain

Flank pain

Fungal skin infection

Furuncle

Rash

Rash pruritic

Rash papular

Night sweats

Haematuria

Lymphadenopathy

Menometrorrhagia

Deafness unilateral

Pneumothorax

Skin abrasion

Eye pain

Aspartate aminotransferase increased

Blood urine present

100%

80%

60%

40%

20%

Study treatment Arm

MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide

DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide

DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide

DS-TB: 2 Months HRZE/ 4 Months HR

DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Part B Group 4Experimental Treatment1 Intervention

6 participants with moderate renal impairment: Stage 3, MDRD (eGFR = 30-59 mL/min) matched to Group 1C will receive a single oral dose of 200 mg pretomanid after the PK and safety of subjects enrolled in Part A have been reviewed

Group II: Part B Group 3Experimental Treatment1 Intervention

6 participants with mild renal impairment: Stage 2, MDRD (eGFR 60-89 mL/min) matched to Group 1B will receive a single oral dose of 200 mg pretomanid after the PK and safety of subjects enrolled in Part A have been reviewed

Group III: Part A Group 2Experimental Treatment1 Intervention

6 participants with Severe renal impairment; Stage 4, Modification of Diet in Renal Disease (MDRD) (eGFR 15-29 mL/min) and End Stage Renal Disease (ESRD) not on dialysis: Stage 5, Modification of Diet in Renal Disease (MDRD) with estimated Glomerular Filtration Rate (eGFR < 15 mL/min) matched to Group 1A will receive a single oral dose of 200 mg pretomanid

Group IV: Part A Group 1AActive Control1 Intervention

6 healthy participants with normal estimated Glomerular Filtration Rate (eGFR > / = 90 mL/min) matched to Group 2 by race, gender, age (+/- 10 years, but between 18 to 70 years of age) and weight at dosing (+/- 20% of weight) will receive a single oral dose of 200 mg pretomanid

Group V: Part B Group 1BActive Control1 Intervention

6 healthy participants with normal eGFR of > / = 90 mL/min matched to Group 3 by race, gender, age (+/- 10 years, but between 18 to 70 years of age) and weight at dosing (+/- 20% of weight ) will receive a single oral dose of 200 mg pretomanid after the PK and safety of subjects enrolled in Part A have been reviewed

Group VI: Part B Group 1CActive Control1 Intervention

6 healthy participants with normal eGFR > / = 90 mL/min matched to Group 4 by race, gender, age (+/- 10 years, but between 18 to 70 years of age) and weight at dosing (+/- 20% of weight) will receive a single oral dose of 200 mg pretomanid after the PK and safety of subjects enrolled in Part A have been reviewed

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PA-824

2010

Completed Phase 3

~1160

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,485,201 Total Patients Enrolled

4 Trials studying Kidney Failure

5,606 Patients Enrolled for Kidney Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has PA-824 met the criteria for acceptance from the Federal Drug Administration?

"At Power, our team assigned PA-824 a score of 1 because it's currently in Phase 1 trials. This means there is limited evidence for its effectiveness and safety."

Answered by AI

What is the size of recruitment for this clinical trial?

"Affirmative. Information hosted on clinicaltrials.gov verifies that the trial, which was initially posted on August 1st 2019, is actively recruiting patients. 36 participants need to be recruited from just one medical centre."

Answered by AI

What is the principal application of PA-824 in clinical settings?

"PA-824 has been effective at treating tuberculosis, drug-resistant TB, and treatment-intolerant pulmonary TB."

Answered by AI

Are there still opportunities for individuals to take part in this investigation?

"The clinical trial is recruiting as referenced on the official website, having been initially posted in August 2019 and most recently updated in November 2022."

Answered by AI

Am I eligible to become part of this experiment?

"This clinical trial is looking for 36 individuals aged 18 to 70, who are afflicted with active tuberculosis. Recruits must also meet these specific criteria: a grasp of the study parameters and signed informed consent; agreement to follow the outlined restrictions; no nicotine usage in past 30 days; QTc interval < 500 milliseconds on ECG; BMI between 18-35 kg/m^2.; women of childbearing potential should utilize an approved contraception method throughout the duration of this research."

Answered by AI

Does this experimental research include participants over the age of 65?

"To qualify for this medical trial, volunteers must be aged between 18-70. For those younger than 18, there are 56 different studies available and 297 trials catered to seniors over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Single-Dose Study to Evaluate the PKs of Pretomanid in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

2023. "Single-Dose Study to Evaluate the PKs of Pretomanid in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03896750.

All > Tuberculosis