A clinical trial to assess the efficacy and safety of mycophenolate modified release tablets in the prophylaxis of acute rejection of renal transplantation

AN OPEN LABEL, RANDOMIZED, CONTROLLED MULTICENTRE STUDY TO ASSESS THE EFFICACY AND SAFETY OF MYCOPHENOLATE MR TABLETS* (PANACEA BIOTEC LTD) IN COMPARISON WITH MYFORTIC (NOVARTIS PHARMACEUTICALS CORPORATION) IN THE PROPHYLAXIS OF ACUTE REJECTION OF RENAL TRANSPLANTATION - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/02/002444

Enrollment

204

Registered

2012-02-24

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: null- Patients with renal transplantation

Interventions

Intervention1: Mycophenolate MR Tablets (Panacea Biotec Ltd): Mycophenolate MR Tablets Dose: 720 mg Duration: 12 weeks Frequency: Two tablets once daily Route: oral Control Intervention1: Myforti

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex, 18-75years 2. Patients having at least 40 Kg of body weight 3. Patients receiving their first kidney transplant 4. Patients willing to give informed consent 5. Patients able to take oral medications 6. Patients having negative T-cell cross match

Exclusion criteria

Exclusion criteria: 1. Pregnant women and lactating women 2. Women who do not agree to use adequate method for contraception 3. Recipient of paediatric enbloc kidney 4. WBC count of 2,500 cells/mm3, platelet count 1000X 103 cells/mm3 or Hb 6 g% 5. Patients who have receiveda multi-organ transplant 6. Systemic infections requiring continued antibiotic therapy 7. Patients with active liver disease, HBsAg, HCV or HIV positive patients 8. Patients with known hypersensitivity to mycophenolate or any components of the formulation, cyclosporine or steroids 9. Malignancy or history of malignancy other than adequately treated skin carcinoma 10. Patients receiving investigational prophylactic immunosuppressants 11. Patients with active ulcer disease, severe diarrhoea, or any other GI disorder that might interfere with the absorption of medications 12. Patients who do not fully understand the purpose of the study or were already involved in other studies

Design outcomes

Primary

Measure	Time frame
To evaluate that the prevention of acute renal graft rejection episodes with Mycophenolate MR Tablets (Panacea Biotec Ltd) when administered once daily is non inferior to Myfortic (Novartis Pharmaceuticals Corporation) when administered twice daily at the end of 12 weeks of study treatmentTimepoint: 12 weeks of study treatment	—

Secondary

Measure	Time frame
To evaluate that the Renal Graft Function with Mycophenolate MR Tablets (Panacea Biotec Ltd) when administered once daily is non-inferior to Myfortic (Novartis Pharmaceuticals Corporation) when administered twice daily To evaluate that Safety (Incidences of clinical and Laboratory AEs) with Mycophenolate MR Tablets (Panacea Biotec Ltd) when administered once daily is non-inferior to Myfortic (Novartis Pharmaceuticals Corporation) when administered twice dailyTimepoint: 12 weeks of study treatment	—

Measure

Time frame

To evaluate that the Renal Graft Function with Mycophenolate MR Tablets (Panacea Biotec Ltd) when administered once daily is non-inferior to Myfortic (Novartis Pharmaceuticals Corporation) when administered twice daily To evaluate that Safety (Incidences of clinical and Laboratory AEs) with Mycophenolate MR Tablets (Panacea Biotec Ltd) when administered once daily is non-inferior to Myfortic (Novartis Pharmaceuticals Corporation) when administered twice dailyTimepoint: 12 weeks of study treatment

—

Countries

India

Contacts

Public ContactDr Arani Chatterjee

aranichatterjee@panaceabiotec.com011-41679000

Outcome results

None listed

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