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The Efficacy and safety of pretreatment with Prograf in living donor kidney transplantation

The Efficacy and safety of pretreatment with Prograf in living donor kidney transplantation ---a multicenter, open label, randomized control study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000593
Enrollment
Unknown
Registered
2009-11-17
Start date
2009-11-13
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

living donor kidney transplantation

Interventions

Group A:Prograf (routine)+MMF+corticosteroids
Group B:Prograf (pretreatment)+Progrof (routine)+MMF+corticosteroids

Sponsors

309 Hospital of Chinese PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 65 years old; 2. Both male and female are eligible; 3. Body weight ranges from 45 kg to 90 kg; 4. Recipients of a first kidney transplant; 5. A negative pregnancy test prior to receiving study medication; 6. Women of childbearing potential are willing to use contraception; 7. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Re-transplantation or transplantation other than kidney; 2. ABO incompatible transplantation; 3. Antibody induction therapy is required prior to transplantation; 4. PRA>10%; 5. Severe hepatic disease. Defined as: SGPT/ALT, SGOT/AST or total bilirubin increase to more than twice of normal level within 28 days before transplantation; 6. Uncontrolled infection; 7. Severe diarrhea or vomiting, active upper peptic ulcer or malabsorption; 8. Severe cardiac, pulmonary diseases, impaired glucose tolerance or history of malignancy; 9. Allergy to tacrolimus, MMF; 10. Pregnancy or lactation woman.

Design outcomes

Primary

MeasureTime frame
Recipient survival rate;Graft survival rate;Acute rejection or biopsy confirmed acute rejection;

Secondary

MeasureTime frame
Delayed graft function (DGF) rate;Renal function (Creatinine clearance and serum cretine);

Countries

China

Contacts

Public ContactBingyi Shi
shibingyi@medmail.com.cn+86 10 66775188

Outcome results

None listed

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