Comparison of cyclosporine-based, twice daily tacrolimus and once daily sustained-release tacrolimus based-regimen in renal transplant recipients a clinical trial.

Comparison of cyclosporine-based, twice daily tacrolimus and once daily sustained-release tacrolimus based-regimen in renal transplant recipients: A randomized, controlled, open-label, multi-centre clinical trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002429

Enrollment

Unknown

Registered

2012-08-17

Start date

2012-07-01

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

post-transplant

Interventions

cyclosporin:Oral cyclosporine

Tacrolimus Capsules:Oral tacrolimus capsule

Tacrolimus Sustained-release Capsules:Oral tacrolimus sustained-release capsules

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65, male or female; 2. KTx >=6 months; 3. Patients have received cyclosporine-based immunosuppressive therapy for more than 6 months, and have maintained a stable regimen for at least 8 weeks before enrollment; 4. The trough blood level of cyclosporine maintained at 50-200ng/ml at least 4 weeks before enrollment; 5. Cr< 200 umol/l (2.3 mg/dl); 6. Women of childbearing age commit birth control during the trial; 7. Understand and sign the approved informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who have had other solid organ transplantations; 2. 24 hours proteinuria>2g; 3. SGPT/ALT, SGOT/AST or total bilirubin rising to more than double the normal level; 4. Patients suffering from serious infection lesions; 5. Patients have severe diarrhea or vomiting, peptic ulcer and/or defective absorption; 6. Patients have severe heart, lung disease, abnormal glucose tolerance or malignant tumor history; 7. Allergy to tacrolimus or other basic drugs; 8. Pregnancy or lactating women; 9. Patients have participated in another clinical trial in the past month; 10. Patient refuses to sign informed consent form.

Design outcomes

Primary

Measure	Time frame
Estimated glomerular filtration rate (eGFR);	—

Secondary

Measure	Time frame
Serum creatinine, urine creatinine and urea nitrogen level at weeks 0,8,16,24;QoL score at week 0,8,16,24.;Blood pressure, plasma lipid, liver function and FBG at week 0,8,16,24;Gingival hyperplasia and hypertrichiasis during 24 weeks;The acute rejection rate during 24 weeks.;The trough concentration of tacrolimus at week 0,1,2,4,8,16,24;The trough concentration of cyclosporine at week 0,8,16,24;Other adverse events occurring in the three groups;	—

Measure

Time frame

Serum creatinine, urine creatinine and urea nitrogen level at weeks 0,8,16,24;QoL score at week 0,8,16,24.;Blood pressure, plasma lipid, liver function and FBG at week 0,8,16,24;Gingival hyperplasia and hypertrichiasis during 24 weeks;The acute rejection rate during 24 weeks.;The trough concentration of tacrolimus at week 0,1,2,4,8,16,24;The trough concentration of cyclosporine at week 0,8,16,24;Other adverse events occurring in the three groups;

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Countries

China

Contacts

Public ContactJianming Tan

tanjm156@yahoo.com.cn+86 13375918000

Outcome results

None listed

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