Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Leon Fogelfeld, John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT00708981
First received: June 26, 2008
Last updated: September 30, 2014
Last verified: September 2014

June 26, 2008
September 30, 2014
May 2007
October 2013   (final data collection date for primary outcome measure)
Delay in development in end-stage renal failure in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00708981 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)
Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)

The purpose of this study is to compare the progression of kidney disease in subjects with Diabetes mellitus type 2 and Advanced Diabetic Nephropathy treated by routine follow-up as a general care and in subjects treated by multi-factorial intervention in the Diabetes-Renal Clinic.

In this study, the overall objective is comparison of progression of renal insufficiency in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4) randomized into multifactorial intervention in the Diabetes-Renal Clinic (study group) and into usual care (control group). The multifactorial intervention includes the following: 1. Blood pressure control to the goal of <130/80mmHg and renal protection with reduction of proteinuria to <0.5g/day using a protocol that includes therapy with ACE inhibitors, ARBs or their combination. 2. Tight glucose control using SMBG and Lantus/Apidra self-escalation regimen. 3. Use of hypolipidemic therapy to achieve targets of LDL of < 70 mg/dl, HDL > 40/50 mg/dl (males/females) [since you said that HDL is not a target because there are no meds for it I deleted HDL;] and triglycerides of less than 200 mg/dl. 4. Patient enhanced self-management provided by combined diabetes-renal education curriculum (taught by certified diabetes and renal educators). 5. Behavior and social intervention (motivational interviews and social assessment) provided as needed by social workers. 6. Intense case management that includes close follow-up of visits, laboratory monitoring and other self-adherence behaviors. 7. Weight loss with lifestyle and diet modification.

Control Group will keep on receiving the usual treatment that they used to receive from their respective clinics and the Diabetes-Renal team would not alter their therapy or interfere in their management.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Nephropathy
Other: Multifactorial Intervention

Study group will receive multifactorial intervention for advanced diabetic nephropathy:

Elements of multifactorial intervention:

  1. BP control of <130/80mmHg and renal protection with reduction of proteinuria to <0.5g/day using therapy with ACE inhibitors and/or ARBs.
  2. Tight glucose control with target of HbA1C of 7% and below using SMBG and Lantus/Apidra regimen.
  3. Use of hypolipidemic therapy to achieve targets of LDL < 70 mg/dl, HDL > 40/50 mg/dl (M/F)and TG < 200 mg/dl.
  4. Patient enhanced self-management provided by combined diabetes-renal education curriculum.
  5. Behavior and social intervention
  6. Intense case management that includes close follow-up of visits, laboratory monitoring and other self-adherence behaviors carried out by clinical research coordinators.
  • Active Comparator: Study Group

    Study group will receive multifactorial intervention for advanced diabetic nephropathy:

    Elements of multifactorial intervention:

    1. BP control of <130/80mmHg and renal protection with reduction of proteinuria to <0.5g/day using therapy with ACE inhibitors and/or ARBs.
    2. Tight glucose control with target of HbA1C of 7% and below using SMBG and Lantus/Apidra regimen.
    3. Use of hypolipidemic therapy to achieve targets of LDL < 70 mg/dl, HDL > 40/50 mg/dl (M/F)and TG < 200 mg/dl.
    4. Patient enhanced self-management provided by combined diabetes-renal education curriculum.
    5. Behavior and social intervention
    6. Intense case management that includes close follow-up of visits, laboratory monitoring and other self-adherence behaviors carried out by clinical research coordinators.
    Intervention: Other: Multifactorial Intervention
  • No Intervention: Control Group
    Control Group will keep on receiving the usual treatment that they used to receive from their respective clinics and the Diabetes-Renal team would not alter their therapy or interfere in their management.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. The participant is male or female diagnosed with Type 2 Diabetes mellitus defined by the American Diabetes Association criteria and must be aged 18 to 70 years.
  2. The participant must have documented Advanced Diabetic Nephropathy (ADN) defined as presence of proteinuria or micro/macro-albuminuria and impaired GFR (by MDRD equation) corresponding to Chronic Kidney Disease (CKD) stages 3-4 (moderate-severe i.e. estimated GFR >15ml/min and <60ml/min).

    A. Presence of macroalbuminuria B. Presence of microalbuminuria if no therapy with ACE inhibitors or ARBs C. Presence of current microalbuminuria and previous documentation of macroalbuminuria D. Presence of current microalbuminuria and previous documentation of Diabetic Retinopathy or laser therapy E. If only microalbuminuria and no A, B, C or D US of kidney shows NL size.

  3. Minimal cognitive function for a diabetes self management
  4. Fasting or random Blood glucose <400mg/DL

Exclusion Criteria:

  1. Patients with Type 1 Diabetes Mellitus.
  2. Serum Creatinine > 4.0 mg/dl and/or an estimated GFR of < 15 ml/min.
  3. Patients on renal replacement therapy.
  4. Patients with Hyperkalemia (K>5.0 meq/L).
  5. Patients with known Renal Artery stenosis.
  6. Patients with known cancer, hepatic impairment, dementia or other chronic medical diseases.
  7. Patients with severe heart failure (NYHA Class III or IV symptoms and/or LVEF <25%).
  8. Patients with valvular or outflow tract obstruction.
  9. Patients with significant disability that precludes regular attendance at clinics for follow-up.
  10. Patients unwilling or unable to provide informed consent.
  11. Pregnant or lactating women.
  12. Current addiction to substance or alcohol abuse.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00708981
Metabolism IST, IRB# 06-177
Yes
Leon Fogelfeld, John H. Stroger Hospital
John H. Stroger Hospital
Sanofi
Principal Investigator: Leon Fogelfeld, MD John H. Stroger, Jr. Hospital of Cook County, Endocrinology
John H. Stroger Hospital
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP