Multi-center, open-label, non-controlled study of the efficacy and safety of cyclosporine switched to Tacrolimus extended release capsules in renal transplant recipients.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONC-10001519

Enrollment

Unknown

Registered

2010-11-05

Start date

2010-11-01

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 transplant recipient

Interventions

Case series:tacrolimus extended release capsules replacing cyclosporine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years old, male or female; 2. At least six months after renal transplantation; 3. Being with cyclosporine-based immunosuppression therapy for at least 6 months and less than 5 years, and the treatment regimen was stable at least in the last 4 weeks before enrollment; 4. The dose of cyclosporine was stable at least in the last 4 weeks before enrollment; 5. At least one of the following cyclosporine-related adverse reactions existed or the answer of the 5th question on the questionnaire is "YES" (See Appendix 1) (1) patients being with gingival hyperplasia and propose for a treatment; (2) patients with hirsutism and calls for interventionc) patients with high blood pressure after transplantationd) patients with hyperlipidemia after transplantation (total cholesterol> 5.7 mmol/L (220 mg/dl)); 6. serum creatinine <200 umol/l (2.3 mg/dl); 7. Female patients of childbearing age committed to contraception during the trial; 8. Informed consent form signed.

Exclusion criteria

Exclusion criteria: 1. patients with other organ transplantation except kidney; 2. 24-hour proteinuria 2g; 3. SGPT / ALT, SGOT / AST or total bilirubin rising persistently, more than 2 times higher than normal value; 4. uncontrolled infection lesions; 5. patients with severe diarrhea or vomiting, active peptic ulcer or malabsorption; 6. patients with serious heart or lung disease, impaired glucose tolerance or a history of malignancy; 7. Allergic to tacrolimus and any other basic medicine; 8. Female patients during pregnancy or breast-feeding; 9. Enrolled for another clinical study in the last 1 month; 10. other situation that is not suitable for the participation according to doctors.

Design outcomes

Primary

Measure	Time frame
creatinine level;	—

Secondary

Measure	Time frame
the incidence of rejection;the changes of Gingival hyperplasia, hirsutism situation;the tacrolimus blood concentration;creatinine level;the incidence of adverse events.;the changes of blood pressure, lipids, liver function;	—

Countries

China

Contacts

Public ContactBingyi Shi

shibingyi@medmail.com.cn+86 010 66775188

Outcome results

None listed

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