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A registry to collect and evaluate data of clinical experience (treatment experience )in patients who were treated with Thymoglobuline as a primary therapy or drug which lowers normal immune response in patients undergoing kidney transplantation.

A Registry to describe clinical experience with Thymoglobuline® used as induction immunosuppression in patients undergoing renal transplantation - RISE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/09/009700
Enrollment
400
Registered
2017-09-11
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Health Condition 1: Z940- Kidney transplant status Health Condition 2: null- Renal transplant acute rejection

Interventions

None listed

Sponsors

Sanofi Synthelabo India Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient >= 18 years of age 2. Patient is a candidate for renal transplant 3. The investigator decides to use Thymoglobuline as induction therapy independent of this registry 4. signed informed consent Note-Renal transplant could be a first transplant or a repeat transplant

Exclusion criteria

Exclusion criteria: 1. Active, acute or chronic infections 2. Hypersensitivity to rabbit proteins or any of the excipients 3. Pregnancy or lactation 4. Concurrent participation (or participation in the previous 12 weeks) in any another clinical trial 5.Any contraindication to use of Thymoglobuline 6. Special transplants such as combined kidney and other organ like pancreas transplants, ABO incompatible transplants, and transplant requiring desensitization

Design outcomes

Primary

MeasureTime frame
Acute rejection (as diagnosed by the Investigator as per his normal clinical practice Including both clinically suspected and biopsy proven rejection) during the period of 12 months in patients treated with Thymoglobuline for immunosuppression for renal transplant 2. Graft survival at the end of 6 months and 1 year 3. Infections (including CMV infections) over a period 12 months Renal function using Glomerular Filtration Rate (GFR) assessed by MDRD equation at the end of 6 months and 1 yearTimepoint: 1 year

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactRaviteja Adapa

Sanofi India Limited

Deepa.Chodankar@sanofi.com9096867313

Outcome results

None listed

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