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Metformin in Moderate and Severe Renal Failure (CKD 3-4): A Follow-up Study (METsuiviIRC)

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ClinicalTrials.gov Identifier: NCT02848508
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was:  Not yet recruiting
First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:
To validate on the mid-term in moderate and severe renal failure (CKD 3-4) a nomogram to adapt a fixed metformin daily posology according to renal function on the basis of the first short-term study made by the investigators.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Drug: Metformin Phase 2

Detailed Description:

A first open-label pilot study at different stages of CKD (1-5) (concerning whether or not metformin use is safe provided a dose adjustment is used) has evaluated (i) metformin levels in plasma and in erythrocytes according to an increasing metformin dosage and CKD severity (1-5) and (ii) the prevalence of lactate levels ≥2.5 mmol/L in CKD 3-5. All patients underwent 3 one-week- blocks of metformin treatment at an increasing dosage, each of which followed by a one week-wash- out period: 500 mg/day in the evening (E) in phase 1; 1,000 mg/day (500 mg morning (M) and E) in phase 2; 2,000 mg/day (1,000 mg M and E) in phase 3.

Steady-state trough blood levels were assayed 12 hours after the last dose of metformin. In this study a progressive dose-related increase of the trough metformin levels were observed and in particular in severe CKD stages. No case of severe hyperlactatemia was reported in this study. In continue, the investigators thought to conduct a new study to evaluate safety of metformin in mid-term period of time. For this purpose, metformin will be given at a fixed dose during 4 months: 1) 1,500 mg/day (500 mg M and 1,000 mg E) in stage 3a; 2) 1,000 mg/day (500 mg M and E) in stage 3b; and 3) 500 mg/day (M) in stage 4. Metformin levels in plasma and in erythrocytes, venous lactate, and HbA1c levels will be measured at 1, 2, 3 and 4 months for assessment of safety.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin in Moderate and Severe Renal Failure (CKD 3-4): A Follow-up Study
Study Start Date : September 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: moderate impairment, CKD stage 3a
(12 subjects): GFR 59-45 (moderate impairment, CKD stage 3a) Metformin : 1500mg/day
Drug: Metformin
Other Name: Glucophage

Experimental: moderate impairment, CKD stage 3a)
(12subjects): GFR 44-30 (moderate impairment, CKD stage 3b) Metformin : 1000mg/day
Drug: Metformin
Other Name: Glucophage

Experimental: severe impairment
(12 subjects): GFR 29-15 (severe impairment, CKD stage 4) Metformin : 500mg/day
Drug: Metformin
Other Name: Glucophage




Primary Outcome Measures :
  1. Monitoring of blood metformin plasma levels with a fixed dose of metformin [ Time Frame: 4 months ]
  2. Monitoring of blood metformin erythrocytes levels with a fixed dose of metformin [ Time Frame: 4 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes patients with stable CKD stages 3A, 3B and 4 aged between 18 and 80 years requiring metformin (and any other antidiabetic treatment)

Exclusion Criteria:

  • Hyperlactatemia (> 2.5 mmol/L)
  • No creatinine levels available since 3 months
  • Severe hepatic insufficiency
  • No liver function parameters available
  • Need of investigation with iodized contrast media
  • Hypersensitivity to metformin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848508


Contacts
Contact: Jean-Daniel LALAU, MD, PhD +33 3 22 45 58 95 lalau.jean-daniel@chu-amiens.fr

Locations
France
CHU Amiens Not yet recruiting
Amiens, France, 80054
Contact: Jean-Daniel LALAU, MD, PhD    +33 3 22 45 58 95    lalau.jean-daniel@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Jean-Daniel LALAU, MD, PhD CHU Amiens

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02848508     History of Changes
Other Study ID Numbers: PI2016_843_0009
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Metformin
moderate renal failure
severe renal failure
chronic kidney disease
hyperlactatemia
lactic acidosis

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs