Protection Against Nephropathy in Diabetes with Atorvastatin

ISRCTN ISRCTN58196433
DOI https://doi.org/10.1186/ISRCTN58196433
Secondary identifying numbers N/A
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

Study designA double-blinded parallel study, randomised by block design and stratified by centre.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleProtection Against Nephropathy in Diabetes with Atorvastatin
Study acronymPANDA
Study objectivesTo 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) studiedType II diabetes with proteinuria
Intervention1 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Atorvastatin
Primary outcome measure1. 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
Secondary outcome measures1. 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
Overall study start date19/11/2004
Completion date30/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants200
Total final enrolment119
Key inclusion criteria1. 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 criteria1. 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 enrolment19/11/2004
Date of final enrolment30/06/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Division of Cardiovascular and Endocrine Science
Manchester
M13 9NT
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

c/o Prof Paul Durrington
Division of Cardiovascular and Endocrine Science
Core Technology Facility (3rd floor)
46 Grafton Street
Manchester
M13 9NT
England
United Kingdom

Phone 0161 275 1201
Email pdurrington@manchester.ac.uk
Website http://www.manchester.ac.uk
ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Industry

Pfizer UK Ltd (UK)

No information available

University of Manchester (Grant ref: R011264) (UK)
Government organisation / Universities (academic only)
Alternative name(s)
The University of Manchester, University of Manchester UK, University of Manchester in United Kingdom, UoM
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

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.