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mTOR Inhibitor
Sirolimus for Aging
Phase 2
Recruiting
Led By Irina Timofte, M.D.
Research Sponsored by Irina Timofte
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Patients should be adults 65-80 years
* Women who are postmenopausal\* or status post-surgical sterilization only
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
"This trial aims to find a new treatment to slow down the aging process and prevent chronic diseases. They are studying a drug called sirolimus, which targets a pathway in the body linked to cell growth
Who is the study for?
This trial is for individuals who are 55 years or older. It's designed to explore if Sirolimus, a drug that affects cell growth and survival, can slow down the aging process and prevent age-related diseases.
What is being tested?
The study tests whether Sirolimus can delay signs of aging by affecting cellular pathways linked to inflammation and chronic disease development. Participants will be randomly assigned to receive either Sirolimus or no treatment in a controlled environment.
What are the potential side effects?
Sirolimus may cause side effects such as increased risk of infections due to its immunosuppressive properties, potential impact on kidney function, mouth sores, and could potentially affect blood cholesterol levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Feasibility of collecting the laboratory biomarkers and analyzing the data regarding annual rate of decline in functional biomarkers of aging
Phenotypic/functional biomarkers of aging
Side effects data
From 2008 Phase 4 trial • 293 Patients • NCT0011874229%
Diarrhoea
18%
Abdominal Pain
16%
Nausea
16%
Headache
16%
Fatigue
16%
Hepatitis C
14%
Vomiting
14%
Pyrexia
14%
Leukopenia
12%
Oedema Peripheral
11%
Insomnia
10%
Anaemia
10%
Hyperkalaemia
10%
Tremor
10%
Back Pain
10%
Hypertension
9%
Cough
9%
Pruritis
9%
Arthralgia
8%
Neutropenia
8%
Abdominal Pain Upper
8%
Dizziness
8%
Pain in Extremity
8%
Hepatic Enzyme Increased
7%
Dyspnoea
7%
Constipation
7%
Sinusitis
7%
Weight Decreased
6%
Blood Creatinine Increased
6%
Liver Function Test Abnormal
6%
White Blood Cell Count Decreased
5%
Muscle Spasms
5%
Jaundice
5%
Renal Failure
5%
Decreased Appetite
5%
Weight Increased
5%
Upper Respiratory Tract Infection
5%
Nasopharyngitis
5%
Asthenia
5%
Incision Site Pain
5%
Depression
4%
Anorexia
4%
Night Sweats
4%
Oropharyngeal Pain
4%
Rhinorrhoea
3%
Hyperlipidaemia
3%
Thrombocytopenia
3%
Pleural Effusion
3%
Myalgia
3%
Rash
3%
Acne
3%
Incisional Hernia
2%
Sepsis
2%
Pneumonia
2%
Hypokalaemia
1%
Renal Failure Acute
1%
Hepatic Neoplasm Malignant
1%
Hypoglycaemia
1%
Urinary Retention
1%
Clostridium Difficile Colitis
1%
Cerebral Haemorrhage
1%
Hepatic Artery Stenosis
1%
Portal Vein Thrombosis
1%
Gastrointestinal Tract Adenoma
1%
Encephalopathy
1%
Atrial Flutter
1%
Transplant Rejection
1%
Confusional State
1%
Blood Alkaline Phosphatase Increased
1%
Multi-Organ Failure
1%
Chest Pain
1%
Non-Small Cell Lung Cancer Metastatic
1%
Benign Prostatic Hyperplasia
1%
Ventricular Tachycardia
1%
Febrile Neutropenia
1%
Hepatic Failure
1%
Epstein-Barr Virus Associated Lymphoproliferative Disorder
1%
Gastritis
1%
Crohn's Disease
1%
Abdominal Hernia
1%
Inappropriate Antidiuretic Hormone Secretion
1%
Gastrointestinal Haemorrhage
1%
Cardiac Failure Congestive
1%
Blood Glucose Increased
1%
Spinal Osteoarthritis
1%
Hypercholesterolaemia
1%
Convulsion
1%
Peritonitis
1%
Haemorrhage Intracranial
1%
Deep Vein Thrombosis
1%
Inguinal Hernia
1%
Viral Infection
1%
Acarodermatitis
1%
Atrial Fibrillation
1%
Malaise
1%
Hepatic Cancer Metastatic
1%
Adenocarcinoma
1%
B-Cell Lymphoma
1%
Desmoid Tumour
1%
Pulmonary Embolism
1%
Stomatitis
1%
Influenza
1%
Staphylococcal Infection
1%
Umbilical Hernia
1%
Hepatic Function Abnormal
1%
Hyponatraemia
1%
Bacteraemia
1%
Cellulitis
1%
Clostridial Infection
1%
Diverticulitis
1%
Escherichia Urinary Tract Infection
1%
Lactobacillus Infection
1%
Lobar Pneumonia
1%
Pseudomonal Sepsis
1%
Post Procedural Haemorrhage
1%
Procedural Pain
1%
Biliary Anastomosis Complication
1%
Complications of Transplanted Kidney
1%
Bile Duct Obstruction
1%
Bile Duct Stenosis
1%
Biliary Tract Disorder
1%
Autoimmune Hepatitis
1%
Cholestasis
1%
Lung Disorder
1%
Pulmonary Oedema
1%
Sinus Congestion
1%
Embolism Venous
1%
Orthostatic Hypotension
1%
Vasculitis
1%
Hyperglycaemia
1%
Graft Versus Host Disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
CellCept + CNI (Tacrolimus or Cyclosporine)
CellCept + Sirolimus
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Patients will be randomized using age-based randomization to initial treatment with 0.5 mg sirolimus p.o. (orally) everyday vs standard of care. The medications would be dispensed from UT Southwestern Medical Center. To ensure patent's safety, all patients will be closely monitored. We will start with a 0.5 mg tablet- the smallest sirolimus dose available. Sirolimus level will be checked weekly in the first month to ensure we maintain a low goal (5-7) that will decrease the risk of developing side effects. In order to monitor study drug compliance, we will ask the patient to keep a pill diary. After the first month, the patient will have monthly blood work and monthly phone call to enquire about potential side effects. The patients will be followed in clinic in person every 3 months. Functional assessment will be obtained at baseline, 3 months 6 months 9 months and 1 year follow up. Completion of the 1-year treatment period will be followed by a follow-up phone call 1 month later.
Group II: ControlActive Control1 Intervention
Interventions: standard of care Patients are not going to receive any additional intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
FDA approved
Find a Location
Who is running the clinical trial?
Irina TimofteLead Sponsor
University of Texas Southwestern Medical CenterLead Sponsor
1,080 Previous Clinical Trials
1,056,303 Total Patients Enrolled
9 Trials studying Aging
516 Patients Enrolled for Aging
Irina Timofte, M.D.Principal InvestigatorUT Southwestern Medical Center
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