Clinical Trials for Diabetic Nephropathy

Clinical trials are research studies conducted in an effort to improve overall patient health and care. Each trial involves running supervised tests to determine the effectiveness and safety of new drugs, procedures and/or devices with the aim of answering scientific questions about a disease or condition. Risks and side-effects are also evaluated during these trials with results ranging from being unpleasant, with side effects such as headaches, to more serious or even life-threatening risks. A clinical trial may be separated into phases, or steps, with each step designed to answer a separate research question. This maybe reflected in the trial name.

A brief description of each phase:

• Phase I: Usually designed to evaluate safety, determine a safe dosage range, and identify side effects on a small group of patients.
• Phase II: If Phase I is successful, the trial is then repeated with a larger group to further evaluate its effect and safety.
• Phase III: Trials are conducted on an ever larger group and are compared with the best current treatment while gathering more information on effect and safety.
• Phase IV: These studies monitor long-term side effects after the treatment has been marketed.

Clinical Trials data for Diabetic Nephropathy is grouped into the following categories:-

• View by trial name
• View by drugs used in Diabetic Nephropathy clinical trials

Clinical Trials by trial name

The format for each of the following is:

• The name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.
• followed by a list of drug/s, if any, used in the trial

ClinicalTrials.gov has listed the following trials for Diabetic Nephropathy:

• Pirfenidone to Treat Kidney Disease in Patients With Diabetes - This study is currently recruiting patients (Current: 23 Nov 2006) - Pirfenidone
• Study of Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes at High Risk of Kidney or Heart Disease - This study has been completed (Current: 23 Nov 2006) - Lisinopril,nifedipine,simvastatin
• Soy Protein in Early Diabetic Nephropathy - This study has been completed (Current: 23 Nov 2006) - soy protein
• Maximal Dose of Angiotensin Converting Enzyme (ACE) Inhibitor for Treatment of Diabetic Kidney Disease - This study is currently recruiting patients (Current: 23 Nov 2006) - Lisinopril
• Effect of Sulodexide in Early Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006) - Sulodexide
• Effect of Sulodexide in Overt Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006) - Sulodexide
• ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial - This study is no longer recruiting patients (Current: 23 Nov 2006) - olmesartan medoxomil
• Antiproteinuric Effect of Valsartan and Lisinopril - This study is no longer recruiting patients (Current: 23 Nov 2006) - VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL
• 6-Month Safety and Efficacy Study of TTP488 in Patients With Type 2 Diabetes and Persistent Albuminuria - This study is currently recruiting patients (Current: 23 Nov 2006) - TTP488
• Immunosuppression Impact on the Metabolic Control of First Kidney Transplant Recipients With Pre-Existing Type 2 Diabetes (DM). - This study is currently recruiting patients (Current: 23 Nov 2006) - Cyclosporin,Tacrolimus
• Linkage Consortium for End-Stage Renal Disease - This study is currently recruiting patients (Current: 23 Nov 2006)
• Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006) - XL784
• Spironolactone in Diabetic Nephropathy - This study has been completed (Current: 23 Nov 2006) - Spironolactone
• Effect of Pyridorin in Patients With Diabetic Nephropathy - This study has been completed (Current: 23 Nov 2006) - Pyridorin (pyridoxamine dihydrochloride)
• Effect of Pyridorin in Patients With Diabetic Nephropathy - This study has been completed (Current: 23 Nov 2006) - Pyridorin (pyridoxamine dihydrochloride)
• Olmesartan Medoxomil and Diabetic Nephropathy - This study has been completed (Current: 23 Nov 2006) - Olmesartan medoxomil,Losartan
• Nitric Oxide (NO) Activity and Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006) - Folic Acid
• A Prospective, Randomised, Double-Blind, Double-Dummy, Forced-Titration, Multicentre, Parallel Group, One Year Treatment Trial to Investigate the Efficacy of Telmisartan 80 Mg Versus Valsartan 160 Mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy - This study has been completed (Current: 23 Nov 2006) - Telmisartan,Valsartan
• A Randomised, Double-Blind, Placebo-Controlled, Multicenter Trial to Investigate the Preventive Effect of BIBR277 (Telmisartan (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan)) in Diabetic Nephropathy on Transition From Incipient to Overt Nephropathy - This study is no longer recruiting patients (Current: 23 Nov 2006) - Telmisartan capsule 40 mg,Telmisartan capsule 80 mg,Placebo
• A Prospective, Randomised, Double-Blind, Double-Dummy, Forced-Titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study) - This study is no longer recruiting patients (Current: 23 Nov 2006) - telmisartan,losartan
• Environmental Exposure to Lead and Progressive Renal Insufficiency in Type II Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006) - EDTA chelating agents
• Comprehensive Management of Diabetic Patients With Renal Impairment : Impact on Blood Pressure and Glycemic Control - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• The Genetics of Kidneys in Diabetes (GoKinD) Study - This study is currently recruiting patients (Current: 23 Nov 2006)
• The Effect of LY333531 on Protein in the Urine in Patients With Type 2 Diabetes - This study has been completed (Current: 23 Nov 2006) - LY333531
• Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes - This study is currently recruiting patients (Current: 23 Nov 2006) - Pirfenidone
• Treatment of Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006) - celecoxib
• Matrix Metalloproteinases and Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Safety and Efficacy of Aliskiren in Patients With Hypertension, Type 2 Diabetes and Proteinuria - This study is currently recruiting patients (Current: 23 Nov 2006) - aliskiren
• Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney - This study has been completed (Current: 23 Nov 2006) - Spironolactone,Irbesartan
• To Determine the Effects of Avosentan on Doubling of Serum Creatinine, End Stage Renal Disease and Death in Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006) - SPP301
• European Trial of Immunosuppression in SPK Tx - This study is no longer recruiting patients (Current: 23 Nov 2006) - sirolimus versus mycophenolate mofetil
• A Study in Patients With Diabetes Mellitus Type II of the Effect on Albuminuria of 24 Week Treatment With Valsartan, Benazepril, and Valsartan+Benazepril - This study is no longer recruiting patients (Current: 23 Nov 2006) - valsartan
• Enhancing Adherence in Type 2 Diabetes: The ENHANCE Study - This study is currently recruiting patients (Current: 23 Nov 2006)
• Maximizing the Benefit of Renin-Angiotensin Blocking Drugs in Diabetic Renal Disease. - This study is currently recruiting patients (Current: 23 Nov 2006) - Addition of furosemide 20 mg oral bid to baseline regimen
• Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006) - ACE inhibitors,ARB, HMG-CoA reductase inhibitors, vitamins
• Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy - This study has been completed (Current: 23 Nov 2006) - nisoldipine,lisinopril
• Eplerenone, ACE Inhibition and Albuminuria - This study is not yet open for patient recruitment (Current: 23 Nov 2006) - eplerenone,fosinopril
• Angiotensin II Antagonism of TGF-Beta 1 - This study has been completed (Current: 23 Nov 2006) - Candesartan
• Renoprotection in Early Diabetic Nephropathy in Pima Indians - This study is no longer recruiting patients (Current: 23 Nov 2006) - Losartan
• Delaying the Progression of Diabetic Nephropathy in Pima Indians - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Effects of Losartan on Insulin Sensitivity and Secretion in Type 2 Diabetes and Nephropathy - This study has been completed (Current: 23 Nov 2006) - losartan
• Pioglitazone and Losartan Provides Additional Renoprotection - This study has been completed (Current: 23 Nov 2006) - pioglitazone,losartan
• High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy - This study is currently recruiting patients (Current: 23 Nov 2006) - High dose ACE-I vs ARB
• Antialbuminuric Effects of Valsartan and Lisinopril - This study is currently recruiting patients (Current: 23 Nov 2006) - VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ
• Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006) - Rosiglitazone
• Sulodexide to Treat Type 2 Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006) - Sulodexide
• Pancreas Transplantation in Man - This study is currently recruiting patients (Current: 23 Nov 2006)
• Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006) - Effects of doxazosin on morning surge in diabetic patients
• The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes - This study is not yet open for patient recruitment (Current: 23 Nov 2006) - Lipoic acid
• Study to Evaluate the Efficacy and Safety of Daglutril Compared to Placebo on Top of Losartan in Type 2 Diabetics With Overt Nephropathy and Well Controlled Hypertension - This study is currently recruiting patients (Current: 23 Nov 2006) - Daglutril
• Family Investigation of Nephropathy and Diabetes (F.I.N.D.) - This study is currently recruiting patients (Current: 23 Nov 2006)

Drugs used in Clinical Trials for Diabetic Nephropathy

The format for each of the following is:

• The drug,
• followed by the name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.

ClinicalTrials.gov has listed the following drugs in trials for Diabetic Nephropathy:

• ACE inhibitors,ARB, HMG-CoA reductase inhibitors, vitamins - Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Addition of furosemide 20 mg oral bid to baseline regimen - Maximizing the Benefit of Renin-Angiotensin Blocking Drugs in Diabetic Renal Disease. - This study is currently recruiting patients (Current: 23 Nov 2006)
• Aliskiren - Safety and Efficacy of Aliskiren in Patients With Hypertension, Type 2 Diabetes and Proteinuria - This study is currently recruiting patients (Current: 23 Nov 2006)
• Candesartan - Angiotensin II Antagonism of TGF-Beta 1 - This study has been completed (Current: 23 Nov 2006)
• Celecoxib - Treatment of Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Cyclosporin - Immunosuppression Impact on the Metabolic Control of First Kidney Transplant Recipients With Pre-Existing Type 2 Diabetes (DM). - This study is currently recruiting patients (Current: 23 Nov 2006)
• Daglutril - Study to Evaluate the Efficacy and Safety of Daglutril Compared to Placebo on Top of Losartan in Type 2 Diabetics With Overt Nephropathy and Well Controlled Hypertension - This study is currently recruiting patients (Current: 23 Nov 2006)
• EDTA chelating agents - Environmental Exposure to Lead and Progressive Renal Insufficiency in Type II Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Effects of doxazosin on morning surge in diabetic patients - Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Eplerenone - Eplerenone, ACE Inhibition and Albuminuria - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Folic Acid - Nitric Oxide (NO) Activity and Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Fosinopril - Eplerenone, ACE Inhibition and Albuminuria - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• High dose ACE-I vs ARB - High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Irbesartan - Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney - This study has been completed (Current: 23 Nov 2006)
• LY333531 - The Effect of LY333531 on Protein in the Urine in Patients With Type 2 Diabetes - This study has been completed (Current: 23 Nov 2006)
• Lipoic acid - The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Lisinopril - Maximal Dose of Angiotensin Converting Enzyme (ACE) Inhibitor for Treatment of Diabetic Kidney Disease - This study is currently recruiting patients (Current: 23 Nov 2006)
• Lisinopril - Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy - This study has been completed (Current: 23 Nov 2006)
• Lisinopril - Study of Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes at High Risk of Kidney or Heart Disease - This study has been completed (Current: 23 Nov 2006)
• Losartan - A Prospective, Randomised, Double-Blind, Double-Dummy, Forced-Titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study) - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Losartan - Effects of Losartan on Insulin Sensitivity and Secretion in Type 2 Diabetes and Nephropathy - This study has been completed (Current: 23 Nov 2006)
• Losartan - Olmesartan Medoxomil and Diabetic Nephropathy - This study has been completed (Current: 23 Nov 2006)
• Losartan - Pioglitazone and Losartan Provides Additional Renoprotection - This study has been completed (Current: 23 Nov 2006)
• Losartan - Renoprotection in Early Diabetic Nephropathy in Pima Indians - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Nifedipine - Study of Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes at High Risk of Kidney or Heart Disease - This study has been completed (Current: 23 Nov 2006)
• Nisoldipine - Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy - This study has been completed (Current: 23 Nov 2006)
• Olmesartan Medoxomil - ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Olmesartan medoxomil - Olmesartan Medoxomil and Diabetic Nephropathy - This study has been completed (Current: 23 Nov 2006)
• Pioglitazone - Pioglitazone and Losartan Provides Additional Renoprotection - This study has been completed (Current: 23 Nov 2006)
• Pirfenidone - Pirfenidone to Treat Kidney Disease in Patients With Diabetes - This study is currently recruiting patients (Current: 23 Nov 2006)
• Pirfenidone - Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes - This study is currently recruiting patients (Current: 23 Nov 2006)
• Placebo - A Randomised, Double-Blind, Placebo-Controlled, Multicenter Trial to Investigate the Preventive Effect of BIBR277 (Telmisartan (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan)) in Diabetic Nephropathy on Transition From Incipient to Overt Nephropathy - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Pyridorin (pyridoxamine dihydrochloride) - Effect of Pyridorin in Patients With Diabetic Nephropathy - This study has been completed (Current: 23 Nov 2006)
• Pyridorin (pyridoxamine dihydrochloride) - Effect of Pyridorin in Patients With Diabetic Nephropathy - This study has been completed (Current: 23 Nov 2006)
• Rosiglitazone - Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006)
• SPP301 - To Determine the Effects of Avosentan on Doubling of Serum Creatinine, End Stage Renal Disease and Death in Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Simvastatin - Study of Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes at High Risk of Kidney or Heart Disease - This study has been completed (Current: 23 Nov 2006)
• Sirolimus Versus Mycophenolate Mofetil - European Trial of Immunosuppression in SPK Tx - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Soy Protein - Soy Protein in Early Diabetic Nephropathy - This study has been completed (Current: 23 Nov 2006)
• Spironolactone - Spironolactone in Diabetic Nephropathy - This study has been completed (Current: 23 Nov 2006)
• Spironolactone - Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney - This study has been completed (Current: 23 Nov 2006)
• Sulodexide - Effect of Sulodexide in Early Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Sulodexide - Effect of Sulodexide in Overt Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Sulodexide - Sulodexide to Treat Type 2 Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006)
• TTP488 - 6-Month Safety and Efficacy Study of TTP488 in Patients With Type 2 Diabetes and Persistent Albuminuria - This study is currently recruiting patients (Current: 23 Nov 2006)
• Tacrolimus - Immunosuppression Impact on the Metabolic Control of First Kidney Transplant Recipients With Pre-Existing Type 2 Diabetes (DM). - This study is currently recruiting patients (Current: 23 Nov 2006)
• Telmisartan capsule 40 mg - A Randomised, Double-Blind, Placebo-Controlled, Multicenter Trial to Investigate the Preventive Effect of BIBR277 (Telmisartan (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan)) in Diabetic Nephropathy on Transition From Incipient to Overt Nephropathy - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Telmisartan capsule 80 mg - A Randomised, Double-Blind, Placebo-Controlled, Multicenter Trial to Investigate the Preventive Effect of BIBR277 (Telmisartan (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan)) in Diabetic Nephropathy on Transition From Incipient to Overt Nephropathy - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Telmisartan - A Prospective, Randomised, Double-Blind, Double-Dummy, Forced-Titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study) - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Telmisartan - A Prospective, Randomised, Double-Blind, Double-Dummy, Forced-Titration, Multicentre, Parallel Group, One Year Treatment Trial to Investigate the Efficacy of Telmisartan 80 Mg Versus Valsartan 160 Mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy - This study has been completed (Current: 23 Nov 2006)
• VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ - Antialbuminuric Effects of Valsartan and Lisinopril - This study is currently recruiting patients (Current: 23 Nov 2006)
• VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL - Antiproteinuric Effect of Valsartan and Lisinopril - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Valsartan - A Prospective, Randomised, Double-Blind, Double-Dummy, Forced-Titration, Multicentre, Parallel Group, One Year Treatment Trial to Investigate the Efficacy of Telmisartan 80 Mg Versus Valsartan 160 Mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy - This study has been completed (Current: 23 Nov 2006)
• Valsartan - A Study in Patients With Diabetes Mellitus Type II of the Effect on Albuminuria of 24 Week Treatment With Valsartan, Benazepril, and Valsartan+Benazepril - This study is no longer recruiting patients (Current: 23 Nov 2006)
• XL784 - Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy - This study is currently recruiting patients (Current: 23 Nov 2006)

The trial data on this page has been sourced from

• The U.S. National Library of Medicine (NLM) together with ClinicalTrials.gov

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