Protection Against Nephropathy in Diabetes with Atorvastatin

ISRCTN	ISRCTN58196433
DOI	https://doi.org/10.1186/ISRCTN58196433
Protocol serial number	N/A
Sponsor	University of Manchester (UK)
Funders	Pfizer UK Ltd (UK), University of Manchester (Grant ref: R011264) (UK)

Submission date: 14/02/2008
Registration date: 21/04/2008
Last edited: 23/07/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Paul Durrington
Scientific

Division of Cardiovascular and Endocrine Science
Core Technology Facility (3rd floor)
46 Grafton Street
Manchester
M13 9NT
United Kingdom

Phone	+44 (0)161 275 1201
Email	pdurrington@manchester.ac.uk

Study information

Primary study design	Interventional
Study design	A double-blinded parallel study, randomised by block design and stratified by centre.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Protection Against Nephropathy in Diabetes with Atorvastatin
Study acronym	PANDA
Study objectives	To compare the effect of treatment with a low and high dose HMG CoA reductase inhibitor on the progression of diabetic nephropathy in patients with type II diabetes whose blood pressure will be controlled using antihypertensive regimens that will include angiotensin II receptor antagonists.
Ethics approval(s)	Central Manchester Research Ethics Committee. Date of approval: 28/07/2004 (ref: 04/Q1407/51)
Health condition(s) or problem(s) studied	Type II diabetes with proteinuria
Intervention	1 x 10 mg active atorvastatin (oral) and 2 x 40 mg placebo vs 2 x 40 mg active atorvastatin (oral) and 1 x 10 mg placebo for three years.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Atorvastatin
Primary outcome measure(s)	1. Difference in the mean level of glomerular filtration rates at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily 2. Difference in the mean level of albumin excretion rates at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily
Key secondary outcome measure(s)	1. Change in serum creatinine and GFR between baseline and 3 years follow-up for patients receiving atorvastatin 10 mg and 80 mg daily 2. Difference in the mean level of serum creatinine at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily 3. Difference in the percentage of patients achieving low density lipoprotein (LDL) cholesterol levels <2.6 mmol/l at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily 4. Difference in the percentage of patients who have a cardiovascular event defined as documented non fatal acute myocardial infarction, hospital admission for unstable angina, appearance of new Q waves on electrocardiogram (ECG), coronary heart disease (CHD) death, coronary artery bypass surgery, coronary angioplasty/stenting or lower limb revascularisation, ischaemic stroke shown by abnormal brain scan or permanent neurological deficit, amputation 5. Difference in the percentage of patients who need photocoagulation for diabetic retinopathy within the first 3 years of follow-up between patients receiving atorvastatin 10 mg and 80 mg daily
Completion date	30/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Total final enrolment	119
Key inclusion criteria	1. Type 2 diabetes (defined according to the World Health Organization criteria) previously known to have proteinuria or microalbuminuria 2. Urinary albumin:creatinine ratio greater than 5 mg/mmol on two consecutive urine samples 3. Aged over 40 4. Capable of giving informed consent 5. Consent to inform General Practitioner of inclusion in study
Key exclusion criteria	1. Urinary protein output >2g/24 hours 2. Serum creatinine >= 200 µmol/l 3. Blood pressure >160/90 mmHg at randomisation 4. Women of child bearing potential 5. Serum cholesterol >= 7 mmol/l or fasting serum triglycerides >= 6 mmol/l at any visit 6. Taking >10 mg of atorvastatin at screening 7. Untreated hypothyroidism 8. Hepatic dysfunction, transaminase >2 times the upper limit of normal or alkaline phosphatase >1.5 times the upper limit of normal 9. Any other concomitant illness other than diabetes or its complication likely to effect outcome 10. Concomitant medication that may interact adversely with HMG-CoA reductase inhibitors or ATII receptor antagonists 11. Known intolerance of ATII receptor antagonists or HMG-CoA reductase inhibitors 12. HbA1c >10% at randomisation 13. Current participation in another clinical trial 14. Unable to comply with protocol for other reasons 15. Other lipid lowering medication at randomisation
Date of first enrolment	19/11/2004
Date of final enrolment	30/06/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Division of Cardiovascular and Endocrine Science

Manchester
M13 9NT
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2011		Yes	No
Results article	results	01/01/2018	23/07/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

23/07/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.