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Efficacy and safety of early conversion of low dose calcineurin inhibitor combined with sirolimus to renal transplant patients: a multicenter randomized controlled trial

Efficacy and safety of early conversion of low dose calcineurin inhibitor combined with sirolimus to renal transplant patients: a multicenter randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017277
Enrollment
Unknown
Registered
2018-07-20
Start date
2018-07-31
Completion date
Unknown
Last updated
2020-11-24

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

Conditions

renal transplantation

Interventions

control group:Standard regimen treatment after renal transplantation
Experience group:After 4 weeks of standard treatment, renal transplant recipients were converted to low dose calcineurin inhibitor combined with sirolimus.

Sponsors

Beijing Chaoyang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Voluntarily signing the letter of informed consent; 2) Aged 18~70 years old; 3) prepare to accept end-stage renal disease patients after organ donation donor and living donor kidney transplantation after the death of citizen; 4) before operation, the group reactive antibody was less than 10%; 5) primary renal transplant patients; 6) Glomerular filtration rate was more than 45ml/min.

Exclusion criteria

Exclusion criteria: 1) Signs of systemic or local active infection; 2) chest X-ray examination showed signs of infiltration, cavitation or consolidation; 3) the primary disease of the recipient was diagnosed as focal segmental glomerulosclerosis (FSGS) or membranous proliferative glomerulonephritis (MPGN); 4) patients with multiple organ transplantation; 5) patients with triglycerides exceeding 400mg/dL (> 4.6mmol/L) and total cholesterol > 300mg/dL (> 7.8mmol/L); 6) the 24 hour urine protein was more than 500mg/d; 7) biopsy confirmed acute rejection occurred within the first 4 weeks of admission; 8) patients who were intolerant of 1.5g/d MMF within the first 4 weeks of admission; 9) renal function delayed recovery (DGF) and glomerular filtration rate (45ml/min) were less than 4 weeks before admission; 10) active hepatitis B or active hepatitis C (according to the diagnostic criteria of each center); 11) HIV positive; 12) other research drugs were used in the first 4 weeks of the group; 13) there was a history of cancer in the first 3 years (except for well treated basal cell skin cancer and squamous cell skin cancer); 14) the donor's kidney source was identical twins; 15) preparations for the use of substances known to have strong interactions with sirolimus, including antifungal agents (clotrimazole, fluconazole, itraconazole, ketoconazole, Fushita Yasu), antibiotics (clarithromycin, erythromycin, teliromycin, amidomycin), and gastrointestinal tract (Sisabi Leigh, methoxyclopramide) anticonvulsant Drugs (C Masi Bing, phenobarbital, phenytoin), antituberculous drugs: rifampicin, rifampicin, herbal preparations (Saint John grass (Hypericum perforatum, hypericin), and other drugs (bromocriptine, cimetidine, nalazol), HIV- protease inhibitors (such as rimonavir and ininavir); 16) women in pregnancy, preparation for pregnancy or lactation; Some researchers think that it is not suitable for the use of experimental drugs.

Design outcomes

Primary

MeasureTime frame
creatine;

Countries

China

Contacts

Public ContactWang Wei

Beijing Chaoyang Hospital

zico73@medmail.com+86 13910790920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026