Paired kidney analysis of tacrolimus and cyclosporine microemulsion-based therapy in Chinese cadaveric renal transplant recipients

ISRCTN	ISRCTN45923035
DOI	https://doi.org/10.1186/ISRCTN45923035
Protocol serial number	N/A
Sponsor	Queen Elizabeth Hospital (Hong Kong)
Funder	Queen Elizabeth Hospital (Hong Kong)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Simon Cheung
Scientific

Department of Medicine
Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon
-
Hong Kong

Email	simoncycheung@gmail.com

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To study whether tacrolimus is superior to cyclosporine in preserving renal function
Ethics approval(s)	Yes, 1998
Health condition(s) or problem(s) studied	Cadaveric renal transplant
Intervention	Tacrolimus therapy or Neoral cyclosporine therapy
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Tacrolimus and cyclosporine
Primary outcome measure(s)	Patient and graft survival, rejection rate
Key secondary outcome measure(s)	Course of renal function, cardiovascular risks, infection and malignancy
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key inclusion criteria	Chinese patients receiving first cadaveric renal transplants consecutively between 01/06/98 and 31/12/04 in Queen Elizabeth Hospital in Hong Kong
Key exclusion criteria	Consent not available
Date of first enrolment	01/06/1998
Date of final enrolment	31/12/2004

Department of Medicine

Kowloon
-
Hong Kong

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2006		Yes	No