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Multicenter, prospective study of the effectiveness under immunosuppressive regimens using Myfortic to treat renal transplant recipients from Donation after Circulatory Death in China

Multicenter, prospective study of the effectiveness under immunosuppressive regimens using Myfortic to treat renal transplant recipients from Donation after Circulatory Death in China

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-15006244
Enrollment
Unknown
Registered
2015-04-01
Start date
2015-03-29
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Renal transplantation

Interventions

Case series:Nil

Sponsors

First affiliated hospital, College of Medicine, Zhejiang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. De novo kidney transplantation; 2. Kidneys from adult DCD donors*; 3. Adult recipient; 4. Weight between 50-80 kg; 5. Negative result of pregnancy for women; 6. Provide written informed consent for study participation; 7. Using Simulect as induction therapy; 8. Using EC-MPS at Day 1 after transplantation surgery. * Potential DCD donors are limited to patients who have died, or whose death is imminent, whose medical treatment no longer offers a medical benefit to the patient as determined by the patient, the patient's authorized surrogate, or the patient's advance directive if applicable, in consultation with the healthcare team. Any planned withdrawal of life sustaining medical treatment/support will be carried out in accordance with hospital policy. Prior to the OPO initiating any discussion with the legal next-of-kin about organ donation for a potential DCD donor, the OPO must confirm that the legal next-of-kin has elected to withdraw life sustaining medical treatment. The timing of a potential DCD donor evaluation and donation discussion will be coordinated with the OPO and the patient's healthcare team, in accordance with hospital policy. Death is declared by a healthcare team member in accordance with hospital policy and applicable state and local statues or regulation. A DCD donor may also be called a non-heartbeating, asystolic, or donation after cardiac death donor.

Exclusion criteria

Exclusion criteria: Exclusion criteria Recipient 1. Multi-organ transplantation; 2. ABO blood type incompatibility; 3. PRA>10%; 4. Donor Specific Antibody (DSA) positive; 5. WBC =7.0 mmol/L or 2-hour plasma glucose (2hPG) >=11.1mmol/L Donor; 1. Age beyond 60; 2. Cold ischemia time >18h; 3. Warm ischemia time >30 min; 4. Mean urine volume within 6 hours before donation 10 Days; 6. Last creatinine before donation >200 umol/L.

Design outcomes

Primary

MeasureTime frame
incidence of acute rejection;graft survival rate;patient survival rate;

Countries

China

Contacts

Public ContactChen Zikun, Xu Nan, Chen Jianghua
nan.xu@novartis.com+86 18201752848

Outcome results

None listed

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