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An EpiDemiological Study Evaluating AbdoMinal AOrta CalcificatioN ScoreS in End STage Renal Disease IndiAn PatienTs New to HEmodialysis (DEMONSTRATE)

To assess abdominal aorta calcification (AAC) in End Stage Renal Disease patients new to hemodialysis through Abdominal Aorta Calcification Score (AACS) using lateral abdominal X-Ray.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/006131
Enrollment
1500
Registered
2011-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Dr. Georgi Abraham Madras Medical Mission 4-A, Dr. J. Jayalalitha Nagar, Mogappair, Chennai - 600 037 Telephone: +91-44- 26561801 ext: 2800
Lead Sponsor
Genzyme India Pvt. Ltd., 1st Floor, Technopolis, Golf Course Road, Sector-54, Gurgaon-122 001, Haryana
Collaborator
Max Neeman Medical International Limited, Max House, 1, Dr. Jha Marg Okhla Phase III New Delhi-110020
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patient aged > 18 years. 2. Diagnosed with ESRD and on hemodialysis for at least 4 weeks and maximum of 3 months prior to the signing of the informed consent. 3. The patient must be willing and able to provide written informed consent. 4. If female of child-bearing potential, must have a negative urine/serum pregnancy test. Otherwise, females must have been surgically sterile, or postmenopausal (as documented in medical history) for at least 1 year

Exclusion criteria

Exclusion criteria: 1. Pregnant or breast feeding women. 2. Stage I-IV CKD patients. 3. ESRD patients not on hemodialysis 4. Patients on peritoneal dialysis 5. Unable to comply with study requirements. 6. The patient has any clinically significant disease, other than ESRD or other medical conditions, or serious intercurrent illnesses that, in the opinion of the Investigator, may preclude participation in the study. 7. Any other medical/surgical condition, which in the opinion of the investigator and/or radiologist could interfere with conduct of the lateral lumbar X-ray. 8. Patient has previously undergone kidney transplant.

Design outcomes

Primary

MeasureTime frame
To assess abdominal aorta calcification (AAC) in End Stage Renal Disease (ESRD) patients new to hemodialysis through Abdominal Aorta Calcification Score (AACS) using lateral abdominal X-RayTimepoint: A period of approximately 12 months is anticipated from the time the first patient is enrolled in the study to the completion of the study (last patient out). Each patient?s duration of participation in this epidemiological study is for a maximum of 7 days from the time informed consent is provided by the patient (or discontinuation / withdrawal).—

Secondary

MeasureTime frame
NilTimepoint: Nil—

Countries

India

Contacts

Public ContactDr. Georgi Abraham

Medical Director,

senthilnathan.mohanasundaram@genzyme.com+91 9871666332

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026