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Data collection of the patients receiving Grafalon® (Observational i.e. Non interventional)

Registry for Observational Data Collection from patients receiving Grafalon® (Anti-human T-lymphocyte immunoglobulin)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/02/012258
Enrollment
200
Registered
2018-02-28
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

Health Condition 1: N186- End stage renal disease

Interventions

None listed

Sponsors

Cadila Healthcare Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Renal transplant patients receiving Grafalon® for prevention of acute transplant rejection.

Exclusion criteria

Exclusion criteria: Any reason which may prevent the doctor to enroll the patient in the registry.

Design outcomes

Primary

MeasureTime frame
1. Composite of patient and graft survival 2. The incidence of biopsy proven rejection 3. Incidence of serious infections and malignancy 4. Assessing safety by collecting adverse event data 5. Dose of Grafalon® Timepoint: Registry will be conducted for the duration till sufficient amount of data is collected. data sufficiency will be analyzed post 1 year from start of registry.—

Secondary

MeasureTime frame
NATimepoint: NA—

Countries

India

Contacts

Public ContactDr Jay Kumar Sharma
jaykumar.sharma@zyduscadila.com917948041488

Outcome results

None listed

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